NCT01961583

[18F]Fluciclatide PET Imaging of Pazopanib Response

Evaluation of [18F]FluciclatidePositron Emission Tomography For the Prediction of Response to Pazopanib In Patients With Metastatic Renal Cell Carcinoma: An Exploratory Study

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Kidney Neoplasm

Interventions

Type	Name	Description
DRUG	18F-Fluciclatide	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

Timeline

• Start date: 2013-09-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2013-10-11
• Last updated: 2016-03-01

Locations

1 site across 1 country: South Korea