Positron emission tomography (PET) is a non-invasive imaging tool for monitoring functional and metabolic responses of biological events with specific radiotracer in vivo. The PET tracer \[18F\]Fluciclatide is an 18F radiolabeled small peptide containing the RGD (arginine-glycine-aspartate) tri-peptide, which preferentially binds with high affinity to αvβ3 and αvβ5 integrins. αvβ3-integrins are expressed at low levels on epithelial cells and mature endothelial cells but are expressed at high levels on activated endothelial cells in the neo-vasculature of a range of tumors and it also may regulate angiogenesis. If pazopanib acts mainly on active angiogenetic tumors, the quantitative uptake of \[18F\]Fluciclatide can be used to predict the effect of this antiangiogenic drug. The investigators expected the baseline tumor uptake in \[18F\]Fluciclatide to be able to predict treatment response, and planned a study of \[18F\]FluciclatidePET for patients with metastatic RCC who received pazopanib systemic therapy.
Subjects will receive treatment with pazopanib at a dose of 800 mg orally once daily. \[18F\]Fluciclatide imagings will be taken 2 times; 1) before systemic therapy (at baseline), 2) at one week after starting of Pazopanib. However, If the target lesion on the baseline PET cannot be discriminated compared to the background activity, the 2nd PET will not be done. Response evaluation by CT will be performed at baseline, at 6 week, at 12 week and every 8 weeks thereafter until the end of treatment. RECIST1.1 criteria for response will be applied. Patient will be treated with Pazopanib until there is disease progression, unacceptable toxicity or withdrawal of patient consent.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
12
Baseline 18F-Fluciclatide PET imaging will be obtained before starting of Pazopanib therapy(within 7 days). Subsequent 18F-Fluciclatide PET should be performed on 7 days after Pazopanib therapy
Asan Medical Center
Seoul, Songpa-gu, South Korea
Baseline 18F-Fluciclatide PET SUV
The difference of the baseline 18F-Fluciclatide PET SUV between responders and non-responders by RECIST criteria after Pazopanib therapy
Time frame: Prior to starting Pazopanib treatment
The difference of 18F-Fluciclatide PET parameters (% change of SUV) between responders and non-responders by RECIST criteria
Time frame: 7±1 days after Pazopanib treatment
Progression free survival more than 6 month
Progression free survival defined as time from PET scan to the date of death, recurrence or progression
Time frame: More than 6 month after 1st PET scan
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