Sunitinib for Metastatic Renal Cell Cancer With Imaging Biomarker Assessments for the Early Prediction of Tumor Response

Our proposed clinical study will:

* Provide an exploratory yet reliable and validated cadre of imaging studies done in patients that yield a mechanistically-based understanding of: 1) predictive assays for clinical benefit from standard sunitinib therapy, 2) measurement of efficacy during standard sunitinib therapy, and 3) prognosis or other long term outcomes. * Reveal a more detailed understanding of the in vivo mechanism of standard sunitinib therapy in patient tumors, mechanistic information on why particular functional imaging patterns are seen in treated patients, and clinical measures that are useful to physicians for decision making and for explanation of efficacy or outcomes for patients. * Predict which patients may benefit from standard sunitinib therapy. * Determine early in the course of treatment whether standard sunitinib therapy will be efficacious and whether this can be used in future comparable patients. * Show the outcome of patients with standard sunitinib treatment. * Shed further information on the biological mechanism for the rapid decrease of FDG uptake on FDG-PET imaging with standard sunitinib treatment.

It is our hypothesis that a set of biologically relevant imaging biomarkers (tumor metabolism assessed with dynamic FDG-PET; tumor proliferation assessed with dynamic FLT-PET; tumor blood flow assessed with H215O-PET and DCE MRI); tumor perfusion assessed with DCE-MRI; and tumor blood volume/volume of distribution assessed with H215O-PET and DCE MRI) in the same patient at baseline and then in the same patient at one of the post therapy time points (1 week, 2 weeks, 3 weeks or 4 weeks) will provide either alone or more likely in combination information that will predict which patients will most likely benefit from standard sunitinib therapy and that an early response assessment is possible that is predictive of a durable response to the therapeutic drug.