Evaluating Sunitinib Therapy in Renal Cell Carcinoma Using F-18 FDG PET/CT and DCE MRI

NCT00537056 NA COMPLETED Results posted

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).

Details

Lead sponsor	Stanford University
Phase	NA
Status	COMPLETED
Enrolment	17
Start date	2007-10
Completion	2012-04

Conditions

• Kidney Neoplasms
• Carcinoma, Renal Cell
• Kidney (Renal Cell) Cancer

Interventions

• FDG PET CT
• DCE MRI
• F-18 Fluoro-deoxi-glucose
• Gadolinium-DTPA
• Sunitinib

Primary outcomes

• F-18 FDG Tumor Uptake (SUV Max) — 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.

Countries

United States