Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI
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|ClinicalTrials.gov Identifier: NCT00537056|
Recruitment Status : Completed
First Posted : September 28, 2007
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Kidney Neoplasms Carcinoma, Renal Cell Kidney (Renal Cell) Cancer||Procedure: FDG PET CT Procedure: DCE MRI Drug: F-18 Fluoro-deoxi-glucose Drug: Gadolinium-DTPA Drug: Sunitinib||Not Applicable|
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.
The 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||April 2012|
Experimental: F-18 FDG PET/CT and DCE MRI
FDG PET CT F-18 Fluoro-deoxi-glucose: 15 mCi iv Gadolinium-DTPA: 0.1 mmol/kg Sunitinib: 50 mg/day po
Procedure: FDG PET CT
nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body
Other Name: Positron emission tomography (PET)
Procedure: DCE MRI
DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).
Other Name: Magnetic Resonance Imaging
Drug: F-18 Fluoro-deoxi-glucose
15 mCi iv
0.1 mmol/kg iv
50 mg/day po
- F-18 FDG Tumor Uptake (SUV Max) [ Time Frame: 12 weeks minus baseline ]
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.
Reduction or increased SUVmax will be determined as the change from baseline in uptake of F18 FDG.
Results 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.
- Histopathology [ Time Frame: 1 day ]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.
- Initial Comprehensive Metabolic Panel [ Time Frame: Prior to baseline DCE MRI ]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.
- Adverse Events [ Time Frame: up to 12 months ]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.
- Tumor Necrosis [ Time Frame: 12 weeks ]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.
- Tumor Size by Computed Tomography (CT) Scan [ Time Frame: 12 weeks ]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.
- Tumor Size by DCE Magnetic Resonance Imaging (MRI) Scan [ Time Frame: 12 weeks ]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.
- DCE MRI AUC Peak Flow [ Time Frame: 12 weeks ]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).
- Initial Tumor Size [ Time Frame: pre-sunitinib therapy ]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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Inclusion Criteria:- Measurable disease by RECIST criteria
- Pathologic diagnosis of renal cell cancer
- Advanced (stage IV) renal cell cancer
- Karnofsky performance status of (KPS>70)
- Consent to participate in the clinical trial Exclusion Criteria:- Patients who cannot complete a PET/CT scan.
- Pregnant women.
- Healthy volunteers.
- Patients participating in other research protocols will be excluded from this study.
- Metallic implants (prosthesis, ICD, pacemakers), since these are contraindications for MRI.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00537056
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Dr Andrew Quon||Stanford University|
|Responsible Party:||Andrew Quon, Associate Professor of Radiology (Nuclear Medicine, Stanford University|
|Other Study ID Numbers:||
97807 ( Other Identifier: Stanford University Alternate IRB Approval Number )
RENAL0013 ( Other Identifier: OnCore )
|First Posted:||September 28, 2007 Key Record Dates|
|Results First Posted:||June 14, 2017|
|Last Update Posted:||June 14, 2017|
|Last Verified:||May 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan 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.|
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Angiogenesis Modulating Agents
Physiological Effects of Drugs
Protein Kinase Inhibitors
Molecular Mechanisms of Pharmacological Action