Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-28 @ 10:00 AM
Study NCT ID:
NCT01169350
Status:
TERMINATED
Last Update Posted:
2017-11-17
First Post:
2010-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
18F-Fluoromisonidazole and Fludeoxyglucose F 18 PET/CT Patients With Soft Tissue Sarcoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012509', 'term': 'Sarcoma'}], 'ancestors': [{'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}, {'id': 'C031843', 'term': 'fluoromisonidazole'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jeary@uw.edu', 'phone': '206-598-6244', 'title': 'Dr. Janet F. Eary', 'organization': 'University of Washington'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected 24hr +/- 4 hours after each administration of [18F] FMISO.', 'eventGroups': [{'id': 'EG000', 'title': 'Diagnostic (18F FDG and 18F FMISO PET/CT)', 'description': 'Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.\n\nfludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans\n\n18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans\n\npositron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans\n\ncomputed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans\n\nlaboratory biomarker analysis: Correlative studies', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes From Baseline Hypoxic Volume (HV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (18F FDG and 18F FMISO PET/CT)', 'description': 'Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.\n\nfludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans\n\n18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans\n\npositron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans\n\ncomputed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans\n\nlaboratory biomarker analysis: Correlative studies'}], 'classes': [{'categories': [{'measurements': [{'value': '9.7', 'spread': '11.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and up to 2 years', 'description': 'ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.', 'unitOfMeasure': 'Cm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Study ended with 8 patients imaged at baseline and only 3 patients had 18F FMISO following therapy.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (18F FDG and 18F FMISO PET/CT)', 'description': 'Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.\n\nfludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans\n\n18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans\n\npositron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans\n\ncomputed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans\n\nlaboratory biomarker analysis: Correlative studies'}], 'timeFrame': 'Up to 2 years', 'description': 'Multivariate Cox regression will be used. The outcome is binary and generalized linear models and logistic regression will be employed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study ended. No patients were assessed for overall survival.No data were collected for this assessment.'}, {'type': 'SECONDARY', 'title': 'Disease Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (18F FDG and 18F FMISO PET/CT)', 'description': 'Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.\n\nfludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans\n\n18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans\n\npositron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans\n\ncomputed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans\n\nlaboratory biomarker analysis: Correlative studies'}], 'timeFrame': 'From start of treatment to the follow-up review where recurrent disease is first detected, assessed up to 2 years', 'description': 'Multivariate Cox regression will be used.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study ended. No patients were assessed for disease free survival.No data were collected for this assessment'}, {'type': 'SECONDARY', 'title': 'Response to Radiation Therapy (XRT) by RECIST Criteria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (18F FDG and 18F FMISO PET/CT)', 'description': 'Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.\n\nfludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans\n\n18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans\n\npositron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans\n\ncomputed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans\n\nlaboratory biomarker analysis: Correlative studies'}], 'timeFrame': 'Up to 2 years', 'description': 'Will be approached using multivariate logistic regression.', 'reportingStatus': 'POSTED', 'populationDescription': 'Study ended. No patients were assessed for response to radiation therapy (XRT) by RECIST criteria. No data were collected for this assessment.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diagnostic (18F FDG and 18F FMISO PET/CT)', 'description': 'Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.\n\nfludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans\n\n18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans\n\npositron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans\n\ncomputed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans\n\nlaboratory biomarker analysis: Correlative studies'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Diagnostic (18F FDG and 18F FMISO PET/CT)', 'description': 'Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.\n\nfludeoxyglucose F 18: Undergo 18F FDG and 18F FMISO PET/CT scans\n\n18F-fluoromisonidazole: Undergo 18F FDG and 18F FMISO PET/CT scans\n\npositron emission tomography: Undergo 18F FDG and 18F FMISO PET/CT scans\n\ncomputed tomography: Undergo 18F FDG and 18F FMISO PET/CT scans\n\nlaboratory biomarker analysis: Correlative studies'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61', 'groupId': 'BG000', 'lowerLimit': '45', 'upperLimit': '80'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Received Baseline FDG PET and FMISO PET'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'whyStopped': 'funding source ended earlier than anticipated', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-17', 'studyFirstSubmitDate': '2010-07-23', 'resultsFirstSubmitDate': '2017-06-08', 'studyFirstSubmitQcDate': '2010-07-23', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-17', 'studyFirstPostDateStruct': {'date': '2010-07-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes From Baseline Hypoxic Volume (HV)', 'timeFrame': 'Baseline and up to 2 years', 'description': 'ANOVA and Kruskal-Wallis analysis will be performed across the different categories to look for significant associations.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Up to 2 years', 'description': 'Multivariate Cox regression will be used. The outcome is binary and generalized linear models and logistic regression will be employed.'}, {'measure': 'Disease Free Survival', 'timeFrame': 'From start of treatment to the follow-up review where recurrent disease is first detected, assessed up to 2 years', 'description': 'Multivariate Cox regression will be used.'}, {'measure': 'Response to Radiation Therapy (XRT) by RECIST Criteria', 'timeFrame': 'Up to 2 years', 'description': 'Will be approached using multivariate logistic regression.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Recurrent Adult Soft Tissue Sarcoma', 'Stage I Adult Soft Tissue Sarcoma', 'Stage II Adult Soft Tissue Sarcoma', 'Stage III Adult Soft Tissue Sarcoma', 'Stage IV Adult Soft Tissue Sarcoma']}, 'descriptionModule': {'briefSummary': 'This phase II trial is studying 18F-fluoromisonidazole and fludeoxyglucose F 18 PET/CT scans to see how well they work in assessing oxygen in tumor tissue of patients with soft tissue sarcoma undergoing chemotherapy with or without radiation therapy. Using diagnostic procedures, such as 18F-fluoromisonidazole and fludeoxyglucose F 18 PET scan and CT scan, to find oxygen in tumor cells may help in planning cancer treatment. It may also help doctors predict how well a patient will respond to treatment.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Evaluate the potential of 18F-fluoromisonidazole (\\[18F\\] FMISO) as a non-invasive indicator of tissue hypoxia to provide tumor-imaging data that correlates with tissue markers of hypoxia in patients with soft tissue sarcoma treated with neoadjuvant chemotherapy with or without radiotherapy.\n\nSECONDARY OBJECTIVES:\n\nI. Test \\[18F\\] FMISO tumor uptake as an independent predictor of patient outcome and if it provides additional predictive power over fludeoxyglucose F 18 PET scan.\n\nII. Test \\[18F\\] FMISO tumor uptake as a predictor of response in the subgroup of patients treated with radiotherapy and chemotherapy.\n\nIII. Test the reproducibility of \\[18F\\] FMISO uptake in tumors by imaging the same patients on sequential days in a test-retest protocol.\n\nIV. Determine the relationship between hypoxia-related biomarkers (HIF1-a and VEGF), proliferation biomarkers (microvascular density, p53, and Ki-67), and regional \\[18F\\] FMISO uptake in tumor.\n\nOUTLINE:\n\nPatients undergo fludeoxyglucose F 18 \\[18F\\] FDG and 18F-fluoromisonidazole (\\[18F\\] FMISO) positron emission tomography (PET)/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.\n\nNOTE: Some patients may undergo repeat \\[18F\\] FMISO PET/CT scan within 48 hours after the first \\[18F\\] FMISO scan to evaluate the variability (test-retest) of this imaging measurement.\n\nBlood samples are collected after completion of \\[18F\\] FMISO and \\[18F\\] FDG PET/CT scans for laboratory biomarker studies by IHC assays. Tumor samples from biopsy or surgery are also collected for biomarker studies.\n\nAfter completion of study procedures, patients are followed up periodically for 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically confirmed intermediate- or high-grade soft tissue sarcoma\n\n * Biopsy proven or highly suspicious primary or recurrent disease\n * Tumor size ≥ 2 cm\n* Scheduled to undergo neoadjuvant chemotherapy with or without radiotherapy\n* Life expectancy ≥ 12 months\n* Negative pregnancy test\n* Willing to undergo PET scanning\n* Willing to undergo possible urinary bladder catheterization (for patients with pelvic or proximal thigh tumors)\n* Able to lie on the imaging table for up to 1.5 hours\n* Weight ≤ 400 lbs\n* Not pregnant'}, 'identificationModule': {'nctId': 'NCT01169350', 'briefTitle': '18F-Fluoromisonidazole and Fludeoxyglucose F 18 PET/CT Patients With Soft Tissue Sarcoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase 2 Study of Positron Emission Tomography Imaging With [18F]-Fluoromisonidazole (FMISO) and [18F]-Fluorodeoxyglucose (FDG) for Assessment of Tumor Hypoxia in Soft Tissue Sarcoma', 'orgStudyIdInfo': {'id': 'NCI-2011-01442'}, 'secondaryIdInfos': [{'id': 'NCI-2011-01442', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '8468'}, {'id': 'CDR0000665359'}, {'id': 'UW-8468'}, {'id': '6971', 'type': 'OTHER', 'domain': 'University of Washington Medical Center'}, {'id': '8468', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'N01CM37008-9-0-0', 'link': 'https://reporter.nih.gov/quickSearch/N01CM37008-9-0-0', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (18F FDG and 18F FMISO PET/CT)', 'description': 'Patients undergo 18F FDG and 18F FMISO PET/CT scans before starting neoadjuvant chemotherapy (without or without radiotherapy) and after completion of 4 courses of neoadjuvant therapy.', 'interventionNames': ['Radiation: fludeoxyglucose F 18', 'Other: 18F-fluoromisonidazole', 'Procedure: positron emission tomography', 'Procedure: computed tomography', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'fludeoxyglucose F 18', 'type': 'RADIATION', 'description': 'Undergo 18F FDG and 18F FMISO PET/CT scans', 'armGroupLabels': ['Diagnostic (18F FDG and 18F FMISO PET/CT)']}, {'name': '18F-fluoromisonidazole', 'type': 'OTHER', 'description': 'Undergo 18F FDG and 18F FMISO PET/CT scans', 'armGroupLabels': ['Diagnostic (18F FDG and 18F FMISO PET/CT)']}, {'name': 'positron emission tomography', 'type': 'PROCEDURE', 'description': 'Undergo 18F FDG and 18F FMISO PET/CT scans', 'armGroupLabels': ['Diagnostic (18F FDG and 18F FMISO PET/CT)']}, {'name': 'computed tomography', 'type': 'PROCEDURE', 'description': 'Undergo 18F FDG and 18F FMISO PET/CT scans', 'armGroupLabels': ['Diagnostic (18F FDG and 18F FMISO PET/CT)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Diagnostic (18F FDG and 18F FMISO PET/CT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98109-1023', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Seattle Cancer Care Alliance', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Janet Eary', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}