Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-04-11 @ 3:25 AM
Study NCT ID:
NCT00537056
Status:
COMPLETED
Last Update Posted:
2017-06-14
First Post:
2007-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}, {'id': 'D019786', 'term': 'Gadolinium DTPA'}, {'id': 'D000077210', 'term': 'Sunitinib'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D004369', 'term': 'Pentetic Acid'}, {'id': 'D011073', 'term': 'Polyamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aquon@mednet.ucla.edu', 'phone': '310-983-1419', 'title': 'Andrew Quon, M.D. Professor Division of Nuclear Medicine', 'organization': 'David Geffen School of Medicine at UCLA'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'The utility of the MRI- and CT-scans was significantly limited by low image quality.'}}, 'adverseEventsModule': {'timeFrame': 'up to 12 months', 'description': 'No adverse events were noted, and none are reported.', 'eventGroups': [{'id': 'EG000', 'title': 'F-18 FDG PET/CT and DCE MRI', 'description': '15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'F-18 FDG Tumor Uptake (SUV Max)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-18 FDG PET/CT and DCE MRI', 'description': '15 mCi iv F-18 FDG PET/CT scan'}], 'classes': [{'title': 'Baseline SUVmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.8', 'spread': '5.7', 'groupId': 'OG000'}]}]}, {'title': 'Mean SUVmax, progression-free survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-18.9', 'spread': '15.1', 'groupId': 'OG000'}]}]}, {'title': 'SUVmax, progression/relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '34.0', 'spread': '39.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 weeks minus baseline', 'description': 'The maximum standardized uptake value (SUVmax) is a measurement of tumor metabolism as determined by the PET scan before and after 12-weeks of sunitinib therapy. Decreased SUVmax correlates to a reduction of tumor metabolism. Increased SUVmax correlates to an increase in tumor metabolism.\n\nReduction or increased SUVmax will be determined as the change from baseline in uptake of F18 FDG.\n\nResults were based on the European Organization for Research and Treatment of Cancer (EORTC) for predicting progression free survival. EORTC criteria is a ± 25% change of SUVmax for assessment of progressive disease, stable disease and partial response.', 'unitOfMeasure': 'SUVmax', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients underwent baseline F-18 FDG PET scan. Mean SUVmax at baseline is reported (row 1). 6 participants achieved progression-free survival after post-sunitinib therapy, and their SUVmax values were averaged (row 2). 11 participants had progression or recurrence/relapse of disease and their SUVmax values were averaged (row 3).'}, {'type': 'SECONDARY', 'title': 'Histopathology', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-18 FDG PET/CT and DCE MRI', 'description': '15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 day', 'description': 'Histopathologic findings were correlated to the pre-treatment 18F-fluorodeoxyglucose positron emission tomography (F-18 FDG PET/CT) scan. Outcome is reported as the number of participants for whom both histopathology and F-18 FDG PET/CT indicated that active cancers was present.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with renal cell carcinoma'}, {'type': 'SECONDARY', 'title': 'Initial Comprehensive Metabolic Panel', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-18 FDG PET/CT and DCE MRI', 'description': '15 mCi iv F-18 FDG PET/CT scan'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Prior to baseline DCE MRI', 'description': 'A comprehensive metabolic panel is a blood test that measures sugar (glucose) level, electrolyte and fluid balance, kidney function, and liver function. It was performed prior to the administration of gadolinium contrast. For patients with normal renal function, approximately 90% of gadolinium contrast is excreted through the urinary system. These patients have known renal cell carcinoma, so it was important to perform a metabolic function panel prior to gadolinium injection, specifically to determine kidney function. Reported as the number of patients for whom the initial comprehensive metabolic panel was within institutional standards.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-18 FDG PET/CT and DCE MRI', 'description': '15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to 12 months', 'description': 'Adverse events were monitored for on F-18 FDG PET/CT and DCE MRI imaging days: baseline (n=17); interim (n=12); and post-sunitinib therapy (n=17). Reported as the overall number of adverse events experienced.', 'unitOfMeasure': 'adverse events', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tumor Necrosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-18 FDG PET/CT and DCE MRI', 'description': '15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The DCE MRI image was obtained but image quality was poor and the degree of tumor necrosis could not be determined.', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'The degree of tumor necrosis was measured using values obtained from dynamic contrast enhanced magnetic resonance imaging (DCE MRI) pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tumor Size by Computed Tomography (CT) Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-18 FDG PET/CT and DCE MRI', 'description': '15 mCi iv F-18 FDG PET/CT scan followed by Sunitinib therapy at 50 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The CT scan performed immediately prior to the PET scan was of poor (non-diagnostic) quality and did not provide usable size measurement data.', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Tumor size was measured based on computed tomography (CT) pre- and post-sunitinib therapy. CT was performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tumor Size by DCE Magnetic Resonance Imaging (MRI) Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-18 FDG PET/CT and DCE MRI', 'description': '15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The DCE MRI image was obtained but image quality was poor and provided no useful data from which to determine tumor size.', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Tumor size was measured using values obtained from DCE MRI pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'DCE MRI AUC Peak Flow', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-18 FDG PET/CT and DCE MRI', 'description': '15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The DCE MRI image was obtained but image quality was poor and provided no useful data to determine AUC.', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 weeks', 'description': 'Area under the curve (AUC) was measured using receiver operating characteristic (ROC) curve analysis. ROC curve analysis measures sensitivity (true-positives, correctly diagnosed positive pathologies) against specificity (true-negatives, correctly diagnosed negative pathologies or free of disease) of the DCE MRI scan. An area of 1.0 under the curve would equal a perfect test (with 100% sensitivity; 100% specificity) while an area of 0.5 would equal a useless test (50% sensitivity; 50% specificity).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Initial Tumor Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'F-18 FDG PET/CT and DCE MRI', 'description': '15 mCi iv F-18 FDG PET/CT scan followed by Sunitinib therapy at 50 mg/day.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The CT scan performed immediately prior to the PET scan was of poor image quality (non-diagnostic) and did not provide usable measurement data.', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'pre-sunitinib therapy', 'description': 'Initial tumor size was measured using values obtained from computed tomography (CT) pre-sunitinib therapy. CT is performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'F-18 FDG PET/CT and DCE MRI', 'description': '15 mCi iv F-18 FDG PET/CT scan and DCE MRI using Gadolinium-DTPA: 0.1 mmol/kg iv followed by Sunitinib therapy at 50 mg/day.'}], 'periods': [{'title': 'Baseline PET/CT', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Interim PET/CT', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'scheduling conflicts and/or exposure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}]}, {'title': '12-month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Seventeen previously untreated adult patients with advanced stage IV renal cell carcinoma (RCC) were prospectively recruited to Stanford Hospital and Clinics for a baseline PET/CT scan followed by a 12-month follow-up PET/CT scan post sunitinib therapy.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'F-18 FDG PET/CT and DCE MRI', 'description': 'FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po\n\nFDG PET CT: nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body\n\nDCE MRI: DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).\n\nF-18 Fluoro-deoxi-glucose: 15 mCi iv\n\nGadolinium-DTPA: 0.1 mmol/kg iv\n\nSunitinib: 50 mg/day po'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Stanford Hospital and Clinics', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-12', 'studyFirstSubmitDate': '2007-09-26', 'resultsFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2007-09-27', 'lastUpdatePostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-12', 'studyFirstPostDateStruct': {'date': '2007-09-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'F-18 FDG Tumor Uptake (SUV Max)', 'timeFrame': '12 weeks minus baseline', 'description': 'The maximum standardized uptake value (SUVmax) is a measurement of tumor metabolism as determined by the PET scan before and after 12-weeks of sunitinib therapy. Decreased SUVmax correlates to a reduction of tumor metabolism. Increased SUVmax correlates to an increase in tumor metabolism.\n\nReduction or increased SUVmax will be determined as the change from baseline in uptake of F18 FDG.\n\nResults were based on the European Organization for Research and Treatment of Cancer (EORTC) for predicting progression free survival. EORTC criteria is a ± 25% change of SUVmax for assessment of progressive disease, stable disease and partial response.'}], 'secondaryOutcomes': [{'measure': 'Histopathology', 'timeFrame': '1 day', 'description': 'Histopathologic findings were correlated to the pre-treatment 18F-fluorodeoxyglucose positron emission tomography (F-18 FDG PET/CT) scan. Outcome is reported as the number of participants for whom both histopathology and F-18 FDG PET/CT indicated that active cancers was present.'}, {'measure': 'Initial Comprehensive Metabolic Panel', 'timeFrame': 'Prior to baseline DCE MRI', 'description': 'A comprehensive metabolic panel is a blood test that measures sugar (glucose) level, electrolyte and fluid balance, kidney function, and liver function. It was performed prior to the administration of gadolinium contrast. For patients with normal renal function, approximately 90% of gadolinium contrast is excreted through the urinary system. These patients have known renal cell carcinoma, so it was important to perform a metabolic function panel prior to gadolinium injection, specifically to determine kidney function. Reported as the number of patients for whom the initial comprehensive metabolic panel was within institutional standards.'}, {'measure': 'Adverse Events', 'timeFrame': 'up to 12 months', 'description': 'Adverse events were monitored for on F-18 FDG PET/CT and DCE MRI imaging days: baseline (n=17); interim (n=12); and post-sunitinib therapy (n=17). Reported as the overall number of adverse events experienced.'}, {'measure': 'Tumor Necrosis', 'timeFrame': '12 weeks', 'description': 'The degree of tumor necrosis was measured using values obtained from dynamic contrast enhanced magnetic resonance imaging (DCE MRI) pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs.'}, {'measure': 'Tumor Size by Computed Tomography (CT) Scan', 'timeFrame': '12 weeks', 'description': 'Tumor size was measured based on computed tomography (CT) pre- and post-sunitinib therapy. CT was performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data.'}, {'measure': 'Tumor Size by DCE Magnetic Resonance Imaging (MRI) Scan', 'timeFrame': '12 weeks', 'description': 'Tumor size was measured using values obtained from DCE MRI pre- and post-sunitinib therapy. Gadolinium contrast material given intravenously during the DCE MRI scan is used to improve visualization of blood vessels, tumors, and/or organs.'}, {'measure': 'DCE MRI AUC Peak Flow', 'timeFrame': '12 weeks', 'description': 'Area under the curve (AUC) was measured using receiver operating characteristic (ROC) curve analysis. ROC curve analysis measures sensitivity (true-positives, correctly diagnosed positive pathologies) against specificity (true-negatives, correctly diagnosed negative pathologies or free of disease) of the DCE MRI scan. An area of 1.0 under the curve would equal a perfect test (with 100% sensitivity; 100% specificity) while an area of 0.5 would equal a useless test (50% sensitivity; 50% specificity).'}, {'measure': 'Initial Tumor Size', 'timeFrame': 'pre-sunitinib therapy', 'description': 'Initial tumor size was measured using values obtained from computed tomography (CT) pre-sunitinib therapy. CT is performed immediately prior to the PET scan and is used to determine both the PET scan imaging area and PET image attenuation correction (AC). F-18 FDG PET provides the metabolic and physiologic data while CT provides the anatomical data.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Kidney Neoplasms', 'Carcinoma, Renal Cell', 'Kidney (Renal Cell) Cancer']}, 'descriptionModule': {'briefSummary': 'To learn whether Flourine-18 Fluoro-deoxi-glucose positron emission tomography / computed tomography (F-18 FDG PET/CT) and dynamic contrast enhanced magnetic resonance imaging (DCE MRI) are better predictors of response to therapy than the current standard of care (CT or MRI).', 'detailedDescription': 'This is a single arm prospective trial in patients with newly-diagnosed advanced renal cell cancer (RCC) who were scheduled for sunitinib therapy and utilized an extensive panel of quantitative metrics on baseline and interim FDG PET/CT to evaluate the predictive utility of each of these measurements.\n\nThe objectives were to evaluate the FDG PET/CT measurement parameters for prediction of prognosis after sunitinib therapy in patients with RCC using histopathologic (post-therapy nephrectomy) or clinical follow-up for validation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:- Measurable disease by RECIST criteria\n\n* Pathologic diagnosis of renal cell cancer\n* Advanced (stage IV) renal cell cancer\n* Karnofsky performance status of (KPS\\>70)\n* Consent to participate in the clinical trial Exclusion Criteria:- Patients who cannot complete a PET/CT scan.\n* Pregnant women.\n* Healthy volunteers.\n* Patients participating in other research protocols will be excluded from this study.\n* Metallic implants (prosthesis, ICD, pacemakers), since these are contraindications for MRI.'}, 'identificationModule': {'nctId': 'NCT00537056', 'briefTitle': 'Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI', 'orgStudyIdInfo': {'id': 'IRB-08558'}, 'secondaryIdInfos': [{'id': '97807', 'type': 'OTHER', 'domain': 'Stanford University Alternate IRB Approval Number'}, {'id': 'RENAL0013', 'type': 'OTHER', 'domain': 'OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F-18 FDG PET/CT and DCE MRI', 'description': 'FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po', 'interventionNames': ['Procedure: FDG PET CT', 'Procedure: DCE MRI', 'Drug: F-18 Fluoro-deoxi-glucose', 'Drug: Gadolinium-DTPA', 'Drug: Sunitinib']}], 'interventions': [{'name': 'FDG PET CT', 'type': 'PROCEDURE', 'otherNames': ['Positron emission tomography (PET)'], 'description': 'nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body', 'armGroupLabels': ['F-18 FDG PET/CT and DCE MRI']}, {'name': 'DCE MRI', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance Imaging'], 'description': 'DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).', 'armGroupLabels': ['F-18 FDG PET/CT and DCE MRI']}, {'name': 'F-18 Fluoro-deoxi-glucose', 'type': 'DRUG', 'otherNames': ['fluorodeoxyglucose (18F)', 'Fludeoxyglucose (18F)', '18F-FDG', 'FDG'], 'description': '15 mCi iv', 'armGroupLabels': ['F-18 FDG PET/CT and DCE MRI']}, {'name': 'Gadolinium-DTPA', 'type': 'DRUG', 'otherNames': ['Gadopentetic acid', 'gadopentetate dimeglumine', 'Gd-DTPA', 'Berlex'], 'description': '0.1 mmol/kg iv', 'armGroupLabels': ['F-18 FDG PET/CT and DCE MRI']}, {'name': 'Sunitinib', 'type': 'DRUG', 'otherNames': ['Sutent', 'SU11248'], 'description': '50 mg/day po', 'armGroupLabels': ['F-18 FDG PET/CT and DCE MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Dr Andrew Quon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified (anonymized) patient data is routinely provided upon request. Protecting patient privacy and confidentiality is the utmost consideration when sharing individual patient data. In all cases of data sharing, patient data is always anonymized to protect privacy. All potential identifiers (name, hospital ID, address,etc) are removed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Comprehensive Cancer Network', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Radiology (Nuclear Medicine', 'investigatorFullName': 'Andrew Quon', 'investigatorAffiliation': 'Stanford University'}}}}