Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2025-12-30 @ 12:21 AM
Study NCT ID:
NCT00775268
Status:
TERMINATED
Last Update Posted:
2021-03-11
First Post:
2008-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}, {'id': 'D044963', 'term': 'Biopsy, Fine-Needle'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D001707', 'term': 'Biopsy, Needle'}, {'id': 'D011677', 'term': 'Punctures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'esther.menagonzalez@nih.gov', 'phone': '240-760-6111', 'title': 'Dr. Esther Mena', 'organization': 'National Cancer Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Date treatment consent signed to date off study, approximately 4 years, 7 months and 9 days.', 'description': '8/9 patients were injected with the tracer (FLT) and scanned in the first Arm/Group, and 21/22 in the second Arm/Group. The risk can only be for 8 patients and 21 participants who received FLT scan.', 'eventGroups': [{'id': 'EG000', 'title': 'Participants Scanned at Baseline & After Chemotherapy', 'description': "Patients undergo 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B.\n\nFluorodeoxyglucose F 18: Undergo scans \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans", 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 3, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Participants Scanned in the Evaluation of Residual Masses After Therapy', 'description': "Patients undergo a 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.\n\nBiopsy: Biopsy taken \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected\n\nfine-needle aspiration: sample collected", 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 1, 'seriousNumAtRisk': 21, 'deathsNumAffected': 5, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Chest pain - cardiac', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Scanned in the Evaluation of Residual Masses After Therapy', 'description': "Patients undergo a 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F-18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan to evaluate of a residual tumor mass after patients have completed therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.\n\nBiopsy: Biopsy taken \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected"}], 'classes': [{'title': 'Presence of FLT uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Absence of FLT uptake and FLT uptake lower than normal mediastinum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}, {'title': 'Positive Biopsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Negative Biopsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Biopsy not performed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon signed-rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3.5 years', 'description': 'A positive malignant residual mass was defined as focal 18F- Fluorothymidine (FLT) uptake within the residual mass greater than the normal mediastinal background uptake. FLT uptake within the mass lower than the mediastinal was considered non-malignant. The positive/negative FLT uptake was correlated with biopsy results within the residual mass (presence or absence of malignant tumor cells).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '21/22 participants were analyzed because one participant was not treated ineligible per CT criteria. Data was collected for only the Arm/Group of participants with residual masses.'}, {'type': 'SECONDARY', 'title': '18F- Fluorothymidine (FLT) Uptake Within the Tumor(s) Between Baseline vs Completion of Therapy Scans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Scanned at Baseline & After Chemotherapy', 'description': "Patients undergo 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B.\n\nFluordeoxyglucose F 18: Undergo scans\n\n\\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans\n\ncomputed tomography: Undergo scans"}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.15', 'spread': '2.84', 'groupId': 'OG000'}]}]}, {'title': 'Completion of therapy scans', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.20', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0313', 'groupIds': ['OG000'], 'statisticalMethod': 'Wilcoxon matched-pairs signed rank test', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'up to 4.5 years', 'description': 'FLT uptake within the tumor(s) using standard uptake value (SUVmax) was compared between baseline and completion of therapy scans.', 'unitOfMeasure': 'SUVmax', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "8/9 participants were analyzed at baseline because the FLT dose failed synthesis in 1 participant. 6/9 participants were analyzed at completion of therapy because 1 participant refused to be imaged, 1 participant missed scan appointment, and 1 patient's FLT dose failed synthesis at baseline and was not scanned at completion of therapy either The rows at baseline and completion of therapy represent the pts: 8 patients were scanned at baseline and 6 pts were scanned at completion of therapy."}, {'type': 'SECONDARY', 'title': "Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline Scan and SUVmax After Completion Scan in Responders and Non-responders' Patients", 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Scanned at Baseline & After Chemotherapy', 'description': "Patients undergo 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans"}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.1', 'spread': '2.8', 'groupId': 'OG000'}]}]}, {'title': 'After completion of scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 4.5 years', 'description': 'The SUVmax (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s). SUVmax was calculated at baseline and after completion of therapy.', 'unitOfMeasure': 'Standard Uptake Value (SUV) - units', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '8/9 participants were analyzed at baseline and 6/9 were analyzed after completion of therapy because 6 patients completed the 3 scans (baseline, at 2-cycles and after completion of therapy). This outcome measure data is collected only for one of the Arm/Group. The other group of participants were not scanned at baseline and after treatment. This data is for baseline (8 patients) and after therapy (6 patients). The outcome measure refers to baseline and after completion of therapy.'}, {'type': 'SECONDARY', 'title': 'Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Scanned at Baseline', 'description': "Patients undergo 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline. Fluorodeoxyglucose F 18: Undergo scans \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans"}, {'id': 'OG001', 'title': 'Participants Scanned After Completion of Therapy', 'description': "Patients undergo 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans"}], 'classes': [{'title': 'Patient 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.9', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Patient 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Patient 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Patient 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Patient 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'Patient 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}, {'value': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Group-level (at baseline and after completion of therapy)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4.5 years', 'description': 'The maximum standard uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s).', 'unitOfMeasure': 'SUV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '6/9 participants were analyzed after completion of therapy because the FLT dose failed synthesis in 1 participant at baseline and was not scanned at completion, 1 participant refused to be imaged and 1 participant missed scan appointment. The other group of participants were not scanned at baseline and after treatment.'}, {'type': 'SECONDARY', 'title': '18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Scanned in the Evaluation of Residual Masses After Therapy', 'description': "Patients undergo a 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.\n\nBiopsy: Biopsy taken \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected"}], 'classes': [{'title': 'Patient 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}]}]}, {'title': 'Patient 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.4', 'groupId': 'OG000'}]}]}, {'title': 'Patient 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.1', 'groupId': 'OG000'}]}]}, {'title': 'Patient 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Patient 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}]}]}, {'title': 'Patient 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000'}]}]}, {'title': 'Patient 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.4', 'groupId': 'OG000'}]}]}, {'title': 'Patient 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}]}]}, {'title': 'Patient 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000'}]}]}, {'title': 'Patient 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000'}]}]}, {'title': 'Patient 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}]}]}, {'title': 'Patient 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Patient 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000'}]}]}, {'title': 'Patient 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000'}]}]}, {'title': 'Patient 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}]}]}, {'title': 'Patient 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.8', 'groupId': 'OG000'}]}]}, {'title': 'Patient 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.2', 'groupId': 'OG000'}]}]}, {'title': 'Patient 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Patient 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'Patient 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}]}]}, {'title': 'Patient 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 3.5 years', 'description': 'After 1 hour post-injection of fluorodeoxyglucose (FDG), the maximum uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was calculated was calculated within the residual mass. The ratio between SUVmax within the residual mass and SUVmean in the pool blood was measured.', 'unitOfMeasure': 'SUVmax/Tumor blood ratio', 'reportingStatus': 'POSTED', 'populationDescription': '21/22 participants were analyzed because one participant was not treated ineligible per CT criteria. Data collected only from residual mass Group of patients for this Outcome Measure.'}, {'type': 'SECONDARY', 'title': "3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection", 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Scanned in the Evaluation of Residual Masses After Therapy at 1 Hour Post Injection', 'description': 'Participants with residual masses after therapy were evaluated with FLT-positron-emission tomography (PET)/computed tomography (CT), acquiring the images after 1 hour after the intravenous injection of FLT to evaluate the tumor uptake value at 1 hour post injection.'}, {'id': 'OG001', 'title': 'Participants Scanned in the Evaluation of Residual Masses After Therapy at 2 Hours Post Injection', 'description': 'Participants with residual masses after therapy were evaluated with FLT-positron-emission tomography (PET)/computed tomography (CT), acquiring the images after 2 hours of the intravenous injection of FLT to evaluate the tumor uptake at at 2 hours post injection.'}], 'classes': [{'title': 'Patient 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'The 2 hour scan was not acquired.', 'groupId': 'OG001'}]}]}, {'title': 'Patient 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'OG000'}, {'value': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Patient 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.9', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'The 2 hour scan was not acquired.', 'groupId': 'OG001'}]}]}, {'title': 'Patient 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Patient 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000'}, {'value': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Patient 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.5', 'groupId': 'OG000'}, {'value': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'Patient 7', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Patient 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Patient 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'Patient 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Patient 11', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Patient 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Patient 13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}, {'value': '7.4', 'groupId': 'OG001'}]}]}, {'title': 'Patient 14', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'groupId': 'OG000'}, {'value': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Patient 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Patient 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'groupId': 'OG000'}, {'value': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'Patient 17', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '4.5', 'groupId': 'OG001'}]}]}, {'title': 'Patient 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000'}, {'value': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Patient 19', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Patient 20', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'The 2 hour scan was not acquired.', 'groupId': 'OG001'}]}]}, {'title': 'Patient 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}]}]}, {'title': 'Overall participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 3.5 years', 'description': 'The maximum uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was calculated within the residual mass at 1 h and at 2 hours post-injection of FLT.', 'unitOfMeasure': 'SUV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome measure was collected for Arm/Group of patients with residual tumor masses after therapy. 21/22 participants were analyzed in thisArm/Group because one participant was not scanned with FLT, ineligible per CT criteria. 18/21 were analyzed in the second Arm/Group because no scans were available for three participants at 2 hours post injection.'}, {'type': 'SECONDARY', 'title': 'Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline and at Mid-treatment (Post-2 Cycles) Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Scanned at Baseline, at 2 Cycles & After ChemotherapyChemotherapy', 'description': "Patients undergo 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Fluorodeoxyglucose F 18: Undergo scans \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans"}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '9.15', 'spread': '2.84', 'groupId': 'OG000'}]}]}, {'title': '2-cycles post treatment', 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.63', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 4.5 years', 'description': 'The SUVmax (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s). SUVmax was calculated at baseline and after 2-cycles of therapy.', 'unitOfMeasure': 'SUVmax', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '8/9 participants were analyzed because the FLT dose failed synthesis in 1 participant, 1 participant refused to be imaged.'}, {'type': 'SECONDARY', 'title': 'Time to Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Scanned After Chemotherapy', 'description': "Patients undergo 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B.\n\nFluorodeoxyglucose F 18: Undergo scans \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans"}], 'classes': [{'categories': [{'measurements': [{'value': '18.29', 'spread': '8.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 4.5 years', 'description': "The time to progression (defined as time in months from 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT)-scan until patient progressed) was compared between the two groups (patients with higher Maximum Standard Uptake Value (SUVmax) vs lower SUVmax, using the median SUV value).", 'unitOfMeasure': 'Months', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '3/6 participants were analyzed because 3 did not progress while on study. Data collected only from the Group of patients scanned at baseline and after chemotherapy for this Outcome Measure.'}, {'type': 'SECONDARY', 'title': '18F- Fluorothymidine (FLT) Uptake, Positron-emission Tomography (PET) Standard Uptake Value (SUV)Max in Malignant Residual Tumors Versus Benign Lesions After Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Scanned in the Evaluation of Residual Masses After Therapy', 'description': "Patients undergo 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.\n\nBiopsy: Biopsy taken \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected"}], 'classes': [{'title': 'Malignant Lesions', 'categories': [{'measurements': [{'value': '5.5', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'Benign Lesions', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 4.5 years', 'description': 'FLT uptake was calculated within malignant residual tumors versus benign lesions using maximum standard uptake value (SUVmax).', 'unitOfMeasure': 'SUVmax', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Participants Scanned at Baseline & After Chemotherapy', 'description': "Patients undergo 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B.\n\nFluorodeoxyglucose F 18: Undergo scans \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans"}, {'id': 'OG001', 'title': 'Participants Scanned in the Evaluation of Residual Masses After Therapy', 'description': "Patients undergo a 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.\n\nBiopsy: Biopsy taken \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected"}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Date treatment consent signed to date off study, approximately 4 years, 7 months and 9 days.', 'description': 'Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '8/9 patients were injected with the tracer (FLT) and scanned in the first Arm/Group, and 21/22 in the second Arm/Group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Participants Scanned at Baseline & After Chemotherapy', 'description': "Patients undergo 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B.\n\nFluorodeoxyglucose F 18: Undergo scans \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans"}, {'id': 'FG001', 'title': 'Participants Scanned in the Evaluation of Residual Masses After Therapy', 'description': "Patients undergo a 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.\n\nBiopsy: Biopsy taken \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected"}], 'periods': [{'title': 'Baseline', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Drug not synthesize dose', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Not treated-ineligible per CT', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'After 2 Cycles', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'comment': 'These 21 patients were not scanned after 2-cycles in this Arm. They were only scanned at baseline.', 'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Participant refused to be scanned further', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'After Completion', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Participant missed scan appointment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Participants Scanned at Baseline & After Chemotherapy', 'description': "Patients undergo 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B.\n\nFluorodeoxyglucose F 18: Undergo scans \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans"}, {'id': 'BG001', 'title': 'Participants Scanned in the Evaluation of Residual Masses After Therapy', 'description': "Patients undergo a 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) Positron-emission tomography (PET)/Computed tomography (CT) scan in the evaluation of FDG-positive residual masses after therapy. Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.\n\nBiopsy: Biopsy taken \\[3'-deoxy-3'-\\[F-18\\] fluorothymidine: Undergo scans computed tomography: Undergo scans fine-needle aspiration: sample collected"}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '49.3', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '48.0', 'spread': '17.3', 'groupId': 'BG001'}, {'value': '48.4', 'spread': '16.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Diagnosis', 'classes': [{'title': "Non-Hodgkin's Lymphoma", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': "Hodgkin's Lymphoma", 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Residual Mass Size', 'classes': [{'title': 'Patient 1-Right hilum lymph node', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'BG001'}, {'value': '2.4', 'groupId': 'BG002'}]}]}, {'title': 'Patient 2-Superior mediastinal lymph node', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'BG001'}, {'value': '2.4', 'groupId': 'BG002'}]}]}, {'title': 'Patient 3-Lumbar vertebrae', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'BG001'}, {'value': '2.5', 'groupId': 'BG002'}]}]}, {'title': 'Patient 4-Right pelvic mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9.0', 'groupId': 'BG001'}, {'value': '9.0', 'groupId': 'BG002'}]}]}, {'title': 'Patient 5-Intercostal soft tissue mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'BG001'}, {'value': '2.3', 'groupId': 'BG002'}]}]}, {'title': 'Patient 6-Right cervical lymph node', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.7', 'groupId': 'BG001'}, {'value': '3.7', 'groupId': 'BG002'}]}]}, {'title': 'Patient 7-Anterior mediastinal mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'BG001'}, {'value': '2.7', 'groupId': 'BG002'}]}]}, {'title': 'Patient 8-Anterior mediastinal mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'BG001'}, {'value': '6.8', 'groupId': 'BG002'}]}]}, {'title': 'Patient 9-Internal right iliac lymph node', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'BG001'}, {'value': '2.2', 'groupId': 'BG002'}]}]}, {'title': 'Patient 10-Right pelvic mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'groupId': 'BG001'}, {'value': '2.2', 'groupId': 'BG002'}]}]}, {'title': 'Patient 11-Right paratracheal lymph node', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.0', 'groupId': 'BG001'}, {'value': '2.2', 'groupId': 'BG002'}]}]}, {'title': 'Patient 12-Left inguinal lymph node', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'BG001'}, {'value': '1.6', 'groupId': 'BG002'}]}]}, {'title': 'Patient 13-Left axilla lymph node', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'groupId': 'BG001'}, {'value': '3.0', 'groupId': 'BG002'}]}]}, {'title': 'Patient 14-Gastrohepatic lymph node', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'BG001'}, {'value': '2.8', 'groupId': 'BG002'}]}]}, {'title': 'Patient 15-Right posterior thigh mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'BG001'}, {'value': '2.5', 'groupId': 'BG002'}]}]}, {'title': 'Patient 16-Left abdominal mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Patient 17-Left suprarenal mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'BG001'}, {'value': '4.3', 'groupId': 'BG002'}]}]}, {'title': 'Patient 18-Splenic mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'BG001'}, {'value': '2.3', 'groupId': 'BG002'}]}]}, {'title': 'Patient 19-Right paraaortic lymph node', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.7', 'groupId': 'BG001'}, {'value': '2.7', 'groupId': 'BG002'}]}]}, {'title': 'Patient 20-Right hilum lymph node', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'BG001'}, {'value': '1.6', 'groupId': 'BG002'}]}]}, {'title': 'Patient 21-Mesenteric mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.2', 'groupId': 'BG001'}, {'value': '5.2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'cm', 'populationDescription': 'Measurement of lesions was not required to qualify for scanning in the first Arm/Group. These are 9 different patients scanned before starting chemo (these patients have not Residual Masses). And Note: 21 patients were not scanned after 2-cycles in the Participants Scanned in the Evaluation of Residual Masses After Therapy Arm. They were only scanned at baseline.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-03-08', 'size': 1185448, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-11-02T12:07', 'hasProtocol': True}, {'date': '2013-02-11', 'size': 254302, 'label': 'Informed Consent Form: Early Response Consent', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-11-02T12:08', 'hasProtocol': False}, {'date': '2013-02-11', 'size': 252208, 'label': 'Informed Consent Form: Residual Mass Consent', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_002.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-11-02T12:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2008-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2014-10-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2008-10-17', 'resultsFirstSubmitDate': '2020-11-30', 'studyFirstSubmitQcDate': '2008-10-17', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-02-18', 'studyFirstPostDateStruct': {'date': '2008-10-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Participants With Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)', 'timeFrame': 'Date treatment consent signed to date off study, approximately 4 years, 7 months and 9 days.', 'description': 'Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With the Presence/Absence of Abnormal 18F- Fluorothymidine (FLT) Uptake, and Positive/Negative Biopsy', 'timeFrame': 'Up to 3.5 years', 'description': 'A positive malignant residual mass was defined as focal 18F- Fluorothymidine (FLT) uptake within the residual mass greater than the normal mediastinal background uptake. FLT uptake within the mass lower than the mediastinal was considered non-malignant. The positive/negative FLT uptake was correlated with biopsy results within the residual mass (presence or absence of malignant tumor cells).'}], 'secondaryOutcomes': [{'measure': '18F- Fluorothymidine (FLT) Uptake Within the Tumor(s) Between Baseline vs Completion of Therapy Scans', 'timeFrame': 'up to 4.5 years', 'description': 'FLT uptake within the tumor(s) using standard uptake value (SUVmax) was compared between baseline and completion of therapy scans.'}, {'measure': "Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline Scan and SUVmax After Completion Scan in Responders and Non-responders' Patients", 'timeFrame': 'up to 4.5 years', 'description': 'The SUVmax (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s). SUVmax was calculated at baseline and after completion of therapy.'}, {'measure': 'Tumor Uptake With Fluorothymidine (FLT) - Maximum Standard Uptake Value (SUVmax)', 'timeFrame': 'Up to 4.5 years', 'description': 'The maximum standard uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s).'}, {'measure': '18F-fluorodeoxyglucose (18FDG) Standardized Uptake Values (SUV) Estimated Maximum and Tumor: Blood Pool Ratio at 1-hour Post-injection', 'timeFrame': 'up to 3.5 years', 'description': 'After 1 hour post-injection of fluorodeoxyglucose (FDG), the maximum uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was calculated was calculated within the residual mass. The ratio between SUVmax within the residual mass and SUVmean in the pool blood was measured.'}, {'measure': "3'-Deoxy-3'-[18F]-Fluorothymidine (FLT) Dynamic Influx Parameter (Ki) Standardized Uptake Values (SUV) Estimated Maximum at 1- and 2-hours Post-injection", 'timeFrame': 'up to 3.5 years', 'description': 'The maximum uptake value (SUVmax) (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was calculated within the residual mass at 1 h and at 2 hours post-injection of FLT.'}, {'measure': 'Tumor(s) Maximum Standard Uptake Value (SUVmax) at Baseline and at Mid-treatment (Post-2 Cycles) Scan', 'timeFrame': 'Up to 4.5 years', 'description': 'The SUVmax (defined as radiotracer uptake in a region of interest normalized by the injected activity and body weight) was measured within the tumor(s). The SUVmax was defined as the uptake value of the hottest pixels, within a volume of interest containing the entire tumor(s). SUVmax was calculated at baseline and after 2-cycles of therapy.'}, {'measure': 'Time to Progression', 'timeFrame': 'up to 4.5 years', 'description': "The time to progression (defined as time in months from 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT)-scan until patient progressed) was compared between the two groups (patients with higher Maximum Standard Uptake Value (SUVmax) vs lower SUVmax, using the median SUV value)."}, {'measure': '18F- Fluorothymidine (FLT) Uptake, Positron-emission Tomography (PET) Standard Uptake Value (SUV)Max in Malignant Residual Tumors Versus Benign Lesions After Therapy', 'timeFrame': 'up to 4.5 years', 'description': 'FLT uptake was calculated within malignant residual tumors versus benign lesions using maximum standard uptake value (SUVmax).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['18F-Fluorothymidine', 'PET/CT', 'FLT', 'Lymphoma', 'FDG'], 'conditions': ['Lymphoma']}, 'referencesModule': {'references': [{'pmid': '12196360', 'type': 'BACKGROUND', 'citation': "Spaepen K, Stroobants S, Dupont P, Vandenberghe P, Thomas J, de Groot T, Balzarini J, De Wolf-Peeters C, Mortelmans L, Verhoef G. Early restaging positron emission tomography with ( 18)F-fluorodeoxyglucose predicts outcome in patients with aggressive non-Hodgkin's lymphoma. Ann Oncol. 2002 Sep;13(9):1356-63. doi: 10.1093/annonc/mdf256."}, {'pmid': '17237035', 'type': 'BACKGROUND', 'citation': 'Jemal A, Siegel R, Ward E, Murray T, Xu J, Thun MJ. Cancer statistics, 2007. CA Cancer J Clin. 2007 Jan-Feb;57(1):43-66. doi: 10.3322/canjclin.57.1.43.'}]}, 'descriptionModule': {'briefSummary': "Background:\n\n* Positron emission tomography (PET) uses radioactive substances called radiotracers to locate areas of cancer in the body. For this test, the patient is given an injection of the radiotracer and lies in a large donut-shaped scanner that detects where in the body the radioactivity accumulates. Computed tomography (CT) scans use low dose x-rays that help to better localize where the radioactive tracer is concentrating. PET/CT scans are usually done in lymphoma patients before treatment starts and at the end of treatment to evaluate the response to therapy.\n* PET scans typically use a sugar-like radioactive tracer called fluorodeoxyglucose (FDG) and low-dose x-rays. Sometimes, however, FDG PET scans show what looks like active disease and presence of a mass after chemotherapy even when there are no live cancer cells. Doctors have particular problems in evaluating response to treatment when this happens because they can't tell if the mass is active cancer or just dead tumor cells.\n* An experimental radiotracer called 18F- Fluorothymidine (FLT) has high uptake in active tumor cells and may be better able to evaluate treatment response.\n\nObjectives:\n\n\\- To test the use of FLT PET/CT imaging in assessing treatment response in patients with lymphoma.\n\nEligibility:\n\n\\- Patients 18 years of age or older who are enrolled in a lymphoma therapy study at the National Institutes of Health (NIH) Clinical Center or in the Cancer and Leukemia Group B (CALGB) 50330 study at another location.\n\nDesign:\n\n\\- There are two arms in this study:\n\n* The first arm evaluates FLT as an early predictor of tumor response to therapy. Patients are imaged with FLT and FDG PET before starting treatment, following two cycles of therapy and after treatment ends.\n* The second arm evaluates the ability of FLT to distinguish if a mass that remains after treatment has viable cancer or dead tissue. Patients who have completed treatment and in whom FDG PET shows a remaining tumor mass are imaged with FLT PET. Following the scan, the tumor is biopsied for verification.", 'detailedDescription': 'Background:\n\n* 3-deoxy-3-18F-fluorothymidine (FLT) positron emission tomography (FLT PET)/Compute tomography (CT) has been shown to correlate with the rate of cellular/tumor proliferation.\n* The Imaging Subcommittee of the International Harmonization Project in Lymphoma recommends performing fluorodeoxyglucose (FDG) positron emission tomography (PET) at least 3 weeks, and preferably 6-8 weeks after chemotherapy or chemoimmunotherapy and 8-12 weeks after radiation or chemoradiation therapy due to high FDG accumulation in inflammatory tissues.\n* FLT uptake in inflammatory lesions is less prominent than FDG and it is likely that FLT PET/CT can better differentiate inflammation from tumor.\n* FLT PET/CT imaging is expected to better differentiate between treatment induced inflammation and malignancy and should enable early prediction of therapeutic response.\n* FLT PET/CT imaging is expected to differentiate between residual inflammatory residual masses from residual malignancy and therefore guide appropriate treatment.\n\nPrimary Objectives:\n\n* To estimate the diagnostic accuracy of FLT PET/CT as an early indicator of complete response to therapy in B and T cell lymphoma.\n* To estimate the diagnostic accuracy of FLT PET/CT in the evaluation of residual masses after therapy.\n\nEligibility:\n\n* Participant must be enrolled in a lymphoma therapy study at the National Institutes of Health (NIH) Clinical Center OR be enrolled in the CALGB 50303 study at another site OR undergoing a new course of treatment of lymphoma at another facility. The National Cancer Institute (NCI) Laboratory of Pathology will confirm diagnosis for subjects enrolled at all CALGB study sites.\n* Participants must have a clinical course consistent with lymphoma and have available documentation of lymphoma from either the NCI or from an outside pathology laboratory.\n* Subjects enrolling in the early response arm must undergo baseline FLT PET prior to receiving a new course of lymphoma therapy.\n* Subjects enrolling in the residual mass evaluation arm can be enrolled at the time the FDG avid residual mass is discovered (i.e. no pre-therapy FLT image is required).\n* Subjects can enroll in both arms of the study.\n* Participant must be 18 years or older.\n* Eastern Cooperative Oncology Group (ECOG) Performance score of 0 or 1.\n* Serum glutamic-oxaloacetic transaminase (SGOT), serum glutamic-pyruvic transaminase (SGPT) less than 5 times upper limit of normal (ULN).\n* bilirubin less than or equal to 2 times ULN.\n\nDesign:\n\nThere are 2 arms in this study\n\n* The first arm will assess FLT as an early predictor of tumor response to therapy (treatment naive or recurrent disease). Subjects are imaged with FLT and FDG PET pre-therapy, following 2 cycles of therapy and post therapy.\n* The second arm will assess lymphoma patients with FDG PET positive residual mass. Subjects are imaged with FLT PET prior to standard of care biopsy of residual mass. If initial FDG PET data is not available in Digital Imaging and Communications in Medicine (DICOM) format or is of suboptimal image quality, a repeat FDG PET/CT at the study site may be required.\n\n * We will accrue 70 participants (40 in the early response arm and 30 in the residual mass arm) to this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nParticipant must be enrolled in a lymphoma therapy study at the National Institutes of Health (NIH) Clinical Center OR be enrolled in the Cancer and Leukemia Group B (CALGB) 50303 study at another site OR undergoing a new course of treatment of lymphoma at another facility.\n\nParticipants must have a clinical course consistent with lymphoma and have available documentation of lymphoma from either the National Cancer Institute (NCI) or from an outside pathology laboratory.\n\nParticipant must be 18 years or older.\n\nEastern Cooperative Oncology Group (ECOG) Performance score of 0 or 1.\n\nAbility to provide informed consent. All patients must sign a document of informed consent indicating their understanding of the investigational nature and risks of the study before any protocol related studies are performed.\n\nFor subjects enrolling in early response arm\n\n* Must be enrolled in CALGB 50303 or a lymphoma therapy study at the NIH Clinical Center or undergoing a new course of treatment of lymphoma at another facility\n* Must not have begun lymphoma therapy for this tumor occurrence/ relapse\n* Prior completed therapy does NOT affect eligibility\n\nFor subjects enrolling in the residual FDG avid mass arm\n\n* Must have a residual (18)F-fluorodeoxyglucose (FDG) positron emission tomography (PET) positive mass greater than equal to 1cm, with uptake greater than that of mediastinal blood pool.\n* Participant will undergo a repeat FDG PET/CT scan if the original FDG/PET imaging performed at an outside institution is not of adequate imaging quality for subjects enrolling in the residual FDG mass arm.\n\nEXCLUSION CRITERIA:\n\nKnown allergy to fluorothymidine.\n\nParticipants for whom enrollment would significantly delay (greater than 2 weeks) the scheduled standard of care therapy.\n\nParticipants with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results are excluded.\n\nParticipants with severe claustrophobia not relieved by oral anxiolytic medication or patients weighing greater than 136 kg (weight limit for scanner table).\n\nOther medical conditions deemed by the Principal Investigator (PI) or associates to make the patient ineligible for protocol procedures.'}, 'identificationModule': {'nctId': 'NCT00775268', 'briefTitle': '18F- Fluorothymidine to Evaluate Treatment Response in Lymphoma', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'A Pilot Study of 18F Fluorothymidine (FLT) PET/CT in Lymphoma', 'orgStudyIdInfo': {'id': '080200'}, 'secondaryIdInfos': [{'id': '08-C-0200'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A - Participants Scanned at Baseline & After Chemotherapy', 'description': "Patients undergo 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT) and fluorodeoxyglucose F 18 (FDG) PET/CT scans at baseline, after 2 courses of chemotherapy, and after completion of chemotherapy. Patients with residual FDG-positive mass after completion of therapy may be enrolled in group B.", 'interventionNames': ['Diagnostic Test: fluorodeoxyglucose F 18 Positron Emission Tomography and computed tomography', "Other: [3'-deoxy-3'-[F-18] fluorothymidine", 'Procedure: computed tomography']}, {'type': 'EXPERIMENTAL', 'label': 'Group B - Participants Scanned in the Evaluation of Residual Masses After Therapy', 'description': 'Patients who have completed treatment in whom FDG-PET shows a remaining tumor mass undergo an FLT PET/CT scan . Patients also undergo a biopsy or fine-needle aspiration, if clinically indicated.', 'interventionNames': ['Procedure: Biopsy', 'Diagnostic Test: fluorodeoxyglucose F 18 Positron Emission Tomography and computed tomography', "Other: [3'-deoxy-3'-[F-18] fluorothymidine", 'Procedure: computed tomography', 'Procedure: fine-needle aspiration']}], 'interventions': [{'name': 'Biopsy', 'type': 'PROCEDURE', 'description': 'Biopsy taken', 'armGroupLabels': ['Group B - Participants Scanned in the Evaluation of Residual Masses After Therapy']}, {'name': 'fluorodeoxyglucose F 18 Positron Emission Tomography and computed tomography', 'type': 'DIAGNOSTIC_TEST', 'description': 'Imaging', 'armGroupLabels': ['Group A - Participants Scanned at Baseline & After Chemotherapy', 'Group B - Participants Scanned in the Evaluation of Residual Masses After Therapy']}, {'name': "[3'-deoxy-3'-[F-18] fluorothymidine", 'type': 'OTHER', 'description': 'Undergo scans', 'armGroupLabels': ['Group A - Participants Scanned at Baseline & After Chemotherapy', 'Group B - Participants Scanned in the Evaluation of Residual Masses After Therapy']}, {'name': 'computed tomography', 'type': 'PROCEDURE', 'description': 'Undergo scans', 'armGroupLabels': ['Group A - Participants Scanned at Baseline & After Chemotherapy', 'Group B - Participants Scanned in the Evaluation of Residual Masses After Therapy']}, {'name': 'fine-needle aspiration', 'type': 'PROCEDURE', 'description': 'sample collected', 'armGroupLabels': ['Group B - Participants Scanned in the Evaluation of Residual Masses After Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20301', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Walter Reed National Medical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center, 9000 Rockville Pike', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Esther Mena, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Esther Mena, M.D.', 'investigatorAffiliation': 'National Cancer Institute (NCI)'}}}}