Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2026-03-09 @ 1:59 AM
Study NCT ID:
NCT02599194
Status:
COMPLETED
Last Update Posted:
2019-01-03
First Post:
2015-11-01
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
18F-FSPG PET/CT for Cancer Patients on Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D064726', 'term': 'Triple Negative Breast Neoplasms'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'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'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000623325', 'term': '4-(3-fluoropropyl)glutamic acid'}, {'id': 'C569271', 'term': '(4S)-4-(3-(18F)fluoropropyl)-L-glutamate'}, {'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aiagaru@stanford.edu', 'phone': '(650) 725-4711', 'title': 'Andrei H. Iagaru', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': '18F-FSPG and 18F-FDG Intragroup Comparision', 'description': 'Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.\n\n18F-FSPG: Administered intravenously (IV)\n\n18F-FDG: Administered intravenously (IV)', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 1, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Elevated blood ammonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (4.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}, {'units': 'Lesion locations assessed', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '18F-FSPG and 18F-FDG Intragroup Comparision', 'description': 'Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.\n\n18F-FSPG: Administered intravenously (IV)\n\n18F-FDG: Administered intravenously (IV)'}], 'classes': [{'title': '18F-FSPG', 'categories': [{'measurements': [{'value': '-1.69', 'groupId': 'OG000'}]}]}, {'title': '18F-FDG', 'categories': [{'measurements': [{'value': '-0.64', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 2 years', 'description': 'Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.', 'unitOfMeasure': 'g/mL', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesion locations assessed', 'denomUnitsSelected': 'Lesion locations assessed', 'populationDescription': 'Locations (ie, of lesions) that did not produce an SUVmax value either before or after treatment are omitted from the mean. Note that an analysis "mean of differences" would have a dispersion, but an analysis for "difference of means" is simply the delta (a number) between 2 measures of central tendency (mean), and does not have a dispersion.'}, {'type': 'SECONDARY', 'title': 'Number of Treatment-Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '18F-FSPG and 18F-FDG Intragroup Comparision', 'description': 'Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.\n\n18F-FSPG: Administered intravenously (IV)\n\n18F-FDG: Administered intravenously (IV)'}], 'classes': [{'title': '18F-FSPG', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '18F-FDG', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to up to 2 years', 'description': 'Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'units': 'Lesion locations assessed', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Difference in Lesion Size as Detected by 18F-FSPG', 'description': 'Participants sequentially receive radioimaging agent 18F-FSPG IV followed by PET/CT scan with 60 minutes.\n\n18F-FSPG: Administered intravenously (IV)'}, {'id': 'OG001', 'title': 'Difference in Lesion Size as Detected by 18F-FDG', 'description': 'Participants sequentially receive radioimaging agent 18F-FDG IV followed by PET/CT scan with 60 minutes.\n\n18F-FDG: Administered intravenously (IV)'}], 'classes': [{'title': 'Adrenal / adrenal mass, left', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.', 'groupId': 'OG000'}, {'value': '11.3', 'groupId': 'OG001'}]}]}, {'title': 'Adrenal / hepatic dome', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.', 'groupId': 'OG000'}, {'value': '-2.0', 'groupId': 'OG001'}]}]}, {'title': 'Adrenal / liver metastatis', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.', 'groupId': 'OG000'}, {'value': '-1.3', 'groupId': 'OG001'}]}]}, {'title': 'Adrenal / lung base metastatis, lower lobe right', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.', 'groupId': 'OG000'}, {'value': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'Adrenal / lung metastatis, left', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.', 'groupId': 'OG000'}, {'value': '-0.7', 'groupId': 'OG001'}]}]}, {'title': 'Lung / infrascapular subcut', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Lesion location was not detected by 18F-FDG both before and after treatment, and no difference can be reported for 2-D area.', 'groupId': 'OG001'}]}]}, {'title': 'Lung / abdominal wall, upper quadrant right', 'categories': [{'measurements': [{'value': '7.6', 'groupId': 'OG000'}, {'value': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'Lung / adajcent subcarinal lymph node', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.', 'groupId': 'OG000'}, {'value': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'Lung / aortopulmonary window lymph node', 'categories': [{'measurements': [{'value': '-1.1', 'groupId': 'OG000'}, {'value': '-2.8', 'groupId': 'OG001'}]}]}, {'title': 'Lung / hilar lymph node, left', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.', 'groupId': 'OG000'}, {'value': '-2.3', 'groupId': 'OG001'}]}]}, {'title': 'Lung / infraspinatus mm, right', 'categories': [{'measurements': [{'value': '10.4', 'groupId': 'OG000'}, {'value': '10.2', 'groupId': 'OG001'}]}]}, {'title': 'Lung / lingula nodule', 'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000'}, {'value': '-2.7', 'groupId': 'OG001'}]}]}, {'title': 'Lung / mass, upper lobe left', 'categories': [{'measurements': [{'value': '-8.1', 'groupId': 'OG000'}, {'value': '-6.4', 'groupId': 'OG001'}]}]}, {'title': 'Lung / mass, lower lobe right', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.', 'groupId': 'OG000'}, {'value': '-14.5', 'groupId': 'OG001'}]}]}, {'title': 'Lung / nodule 1, lower lobe right', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.', 'groupId': 'OG000'}, {'value': '-0.8', 'groupId': 'OG001'}]}]}, {'title': 'Lung / nodule 2, upper lobe right', 'categories': [{'measurements': [{'value': '-1.7', 'groupId': 'OG000'}, {'value': '-1.5', 'groupId': 'OG001'}]}]}, {'title': 'Lung / nodule, upper lobe right', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.', 'groupId': 'OG000'}, {'value': '-0.4', 'groupId': 'OG001'}]}]}, {'title': 'Lung / paraesophageal lymph node', 'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Lesion location was not detected by 18F-FDG both before and after treatment, and no difference can be reported for 2-D area.', 'groupId': 'OG001'}]}]}, {'title': 'Lung / post-basal, lower lobe right', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.', 'groupId': 'OG000'}, {'value': '-3.6', 'groupId': 'OG001'}]}]}, {'title': 'Lung / subcarinal lymph node', 'categories': [{'measurements': [{'value': '1.4', 'groupId': 'OG000'}, {'value': '11.4', 'groupId': 'OG001'}]}]}, {'title': 'Renal / adrenal mass, right', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000'}, {'value': '7.1', 'groupId': 'OG001'}]}]}, {'title': 'Renal / aortopulmonary window lymph node, left', 'categories': [{'measurements': [{'value': '1.1', 'groupId': 'OG000'}, {'value': '-1.2', 'groupId': 'OG001'}]}]}, {'title': 'Renal / gluteal subcutaneous nodule', 'categories': [{'measurements': [{'value': '0.2', 'groupId': 'OG000'}, {'value': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'Renal / interlobar', 'categories': [{'measurements': [{'value': '2.4', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Lesion location was not detected by 18F-FDG both before and after treatment, and no difference can be reported for 2-D area.', 'groupId': 'OG001'}]}]}, {'title': 'Renal / kidney midpole, right', 'categories': [{'measurements': [{'value': '-1.2', 'groupId': 'OG000'}, {'value': '-1.4', 'groupId': 'OG001'}]}]}, {'title': 'Renal / omental nodule', 'categories': [{'measurements': [{'value': '-0.2', 'groupId': 'OG000'}, {'value': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'Renal / paratracheal lymph node, right', 'categories': [{'measurements': [{'value': '0.6', 'groupId': 'OG000'}, {'value': '-2.0', 'groupId': 'OG001'}]}]}, {'title': 'Renal / parotid, right', 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Lesion location was not detected by 18F-FSPG both before and after treatment, and no difference can be reported for 2-D area.', 'groupId': 'OG000'}, {'value': '-2.3', 'groupId': 'OG001'}]}]}, {'title': 'Renal / retroperitoneal lymph node, left', 'categories': [{'measurements': [{'value': '1.6', 'groupId': 'OG000'}, {'value': '2.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline and up to 2 years', 'description': 'Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).', 'unitOfMeasure': 'cm2', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesion locations assessed', 'denomUnitsSelected': 'Lesion locations assessed', 'populationDescription': '* Lesion locations not detected both before and after treatment are reported as N/A for 2-D area (in the effect that an assessment could be made with the other radiolabel).\n* Lesions detected at either before or after treatment only are reported as the difference from zero.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '18F-FSPG and 18F-FDG Intragroup Comparision', 'description': 'Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.\n\n18F-FSPG: Administered intravenously (IV)\n\n18F-FDG: Administered intravenously (IV)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '18F-FSPG and 18F-FDG Intragroup Comparision', 'description': 'Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.\n\n18F-FSPG: Administered intravenously (IV)\n\n18F-FDG: Administered intravenously (IV)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.1', 'spread': '13.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Intra-patient comparison of 2 different radiolabels'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2016-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-11', 'studyFirstSubmitDate': '2015-11-01', 'resultsFirstSubmitDate': '2018-09-20', 'studyFirstSubmitQcDate': '2015-11-04', 'lastUpdatePostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-11', 'studyFirstPostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Standard Uptake Value Maximum (SUVmax) Post-treatment', 'timeFrame': 'Baseline and up to 2 years', 'description': 'Standard Uptake Values (SUVs) for the radiotracers labels 18F-FSPG and 18F-FDG were assessed in tumor tissues of study participants, before (baseline), and after therapeutic treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported as the difference of means from baseline to post-treatment (a number without dispersion), for all lesions for which an SUVmax value was assessed. A negative result indicates less uptake of radiotracer suggesting a small volume of tumor.'}], 'secondaryOutcomes': [{'measure': 'Number of Treatment-Related Adverse Events', 'timeFrame': 'Baseline to up to 2 years', 'description': 'Safety and tolerability of 18F-FSPG and 18F-FDG were assessed as treatment-related adverse events, and reported as the number of events related to each treatment, without dispersion.'}, {'measure': 'Change From Baseline in Lesion Size Post-treatment, by 18F-FSPG or 18F-FDGs', 'timeFrame': 'Baseline and up to 2 years', 'description': 'Lesion size in centimeters (cm) were assessed in 2 dimensions from the computed tomography (CT) component of PET/CT and the area in cm2 calculated for lesion locations at baseline and after treatment. Time frame was specified by protocol as at baseline, and at the time of clinical assessments during individual patient regular medical care. The time of the post-treatment assessment was not otherwise explicitly defined but could be anytime within 2 years. The outcome is reported the difference in area in cm² for each lesion (a number without dispersion).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B-Cell Neoplasm', 'Estrogen Receptor Negative', 'HER2/Neu Negative', 'Metastatic Renal Cell Cancer', 'Progesterone Receptor Negative', 'Stage III Mesothelioma', 'Stage III Renal Cell Cancer', 'Stage IIIA Breast Cancer', 'Stage IIIA Non-Small Cell Lung Cancer', 'Stage IIIB Non-Small Cell Lung Cancer', 'Stage IIIC Breast Cancer', 'Stage IV Breast Cancer', 'Stage IV Mesothelioma', 'Stage IV Non-Small Cell Lung Cancer', 'Stage IV Renal Cell Cancer', 'Triple-Negative Breast Carcinoma']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Park P, Hatami N, Rutledge O, Koglin N, Loo B, Fan A, Mittra E. J Nucl Med. 58(suppl 1, no 118), 1 May 2017.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this phase 2 study trial is to evaluate the utility of the radiolabel 18F-FSPG used before and after treatment to diagnose, predict, and evaluate response to therapy in patients with a wide variety of metastatic cancers.', 'detailedDescription': 'OUTLINE:\n\nPatients are evaluated with a PET/CT scan using the radiolabel 18F-FSPG \\[18F-(S)-4-(3-fluoropropyl)-L-glutamic acid\\] or 18F-FDG (\\[18F\\]-fluorodeoxyglucose), before and after therapeutic treatment.\n\nPRIMARY OBJECTIVE:\n\nUptake of the radiolabel 18F-FSPG in patients with biopsy-proven cancer will be evaluated and compared to the uptake of 18F-FDG, before and after therapy (non-specified) in the same group of patients.\n\nSECONDARY OBJECTIVES:\n\n* Compare the agreement of the clinical assessment for cancer status between 18F-FSPG and 18F-FDG.\n* Safety and tolerability of 18F-FSPG and 18F-FDG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Written informed consent\n* Able to complete a PET/CT scan without the use of sedation\n* Females:\n\n * Of childbearing potential must:\n\n * Not be nursing\n * Have a negative serum pregnancy test documented within 48 hours prior to administration of 18F FSPG PET/CT\n * Not of childbearing potential must be:\n\n * Physiologically postmenopausal (cessation of menses for more than 1 year)\n * Surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy)\n* Histologically confirmed cancer that is advanced; metastatic; or otherwise not suitable for surgical resection with curative intent\n* Scheduled to begin therapy\n* The time interval between 18F FSPG PET/CT and standard of care imaging (ie, 18F FDG PET/CT, diagnostic CT, or MRI) should be within 4 weeks (exceptions will be allowed for 6 weeks, if there are no other options)\n* Ideally, there should be no chemotherapy, radiotherapy, or immune/biologic therapy or biopsy between other imaging (PET/CTs, MRI, or diagnostic CTs) and 18F FSPG PET/CT scheduled or performed (exceptions by investigator discretion)\n* No clinically relevant deviations in renal function (serum creatinine \\> grade 2 Common Terminology Criteria for Adverse Events \\[CTCAE\\] version 4.0); maximal interval between confirmation of renal function and injection of 18F FSPG is 1 week\n\nExclusion Criteria:\n\n* Scheduled for surgery and/or another invasive procedure (except biopsy) within the time period of 1 month prior to 18F FSPG administration\n* Known sensitivity to 18F FSPG or components of the preparation\n* Investigator precludes participation for scientific reasons, for reasons of compliance, or for reasons of the patient's safety"}, 'identificationModule': {'nctId': 'NCT02599194', 'briefTitle': '18F-FSPG PET/CT for Cancer Patients on Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'An Exploratory Study of the Role of 18F-FSPG PET/CT Imaging for Cancer Patients Receiving Therapy', 'orgStudyIdInfo': {'id': 'IRB-31855'}, 'secondaryIdInfos': [{'id': 'NCI-2015-01125', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'VARIMG0006', 'type': 'OTHER', 'domain': 'OnCore ID'}, {'id': 'P30CA124435', 'link': 'https://reporter.nih.gov/quickSearch/P30CA124435', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '18F-FSPG and 18F-FDG Intragroup Comparision', 'description': 'Participants sequentially receive radioimaging agents 18F-FSPG and 18F-FDG IV followed by PET/CT scan with 60 minutes.', 'interventionNames': ['Drug: 18F-FSPG', 'Drug: 18F-FDG']}], 'interventions': [{'name': '18F-FSPG', 'type': 'DRUG', 'otherNames': ['18F-labeled (S)-4-(3-[18F]-fluoropropyl)-L-glutamic acid', '18F-labeled (4S)-4-(3-[18F]-fluoropropyl)-L-glutamate', 'BAY94-9392'], 'description': 'Administered intravenously (IV)', 'armGroupLabels': ['18F-FSPG and 18F-FDG Intragroup Comparision']}, {'name': '18F-FDG', 'type': 'DRUG', 'otherNames': ['[18F]-Fluorodeoxyglucose ([18F]-FDG)'], 'description': 'Administered intravenously (IV)', 'armGroupLabels': ['18F-FSPG and 18F-FDG Intragroup Comparision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Andrei M Iagaru, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Andrei Iagaru', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Radiology', 'investigatorFullName': 'Andrei Iagaru', 'investigatorAffiliation': 'Stanford University'}}}}