NCT00537056

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	FDG PET CT	nuclear medicine imaging technique which produces a three-dimensional image or picture of functional processes in the body
PROCEDURE	DCE MRI	DCE MRI will be acquired using rapid intravenous bolus of gadolinium-DTPA (0.1 mmol/kg).
DRUG	F-18 Fluoro-deoxi-glucose	15 mCi iv
DRUG	Gadolinium-DTPA	0.1 mmol/kg iv
DRUG	Sunitinib	50 mg/day po

Timeline

• Start date: 2007-10-01
• Primary completion: 2011-10-01
• Completion: 2012-04-01
• First posted: 2007-09-28
• Last updated: 2017-06-14
• Results posted: 2017-06-14

Locations

1 site across 1 country: United States