PET Imaging Of Renal Cell Carcinoma With 18F-VM4-037: A Phase II Pilot Study For Detection Of Disease And Correlation With VHL Mutation Status
- Carbonic Anhydrase IX (CA IX) is a hypoxia-inducible enzyme regulated by the VHL
protein that is commonly overexpressed in certain malignancies including renal cell
carcinoma (RCC) and may have prognostic significance.
- The VHL gene is commonly mutated or inactivated in RCC tumors and VHL activity
regulated the expression and activity of not only CAIX but also CAXII as well as other
genes critical for tumor angiogenesis such as VEGF, GLUT1, GLUT 3 and PDGF.
- 18F-VM4-037 is an imaging drug product formulation which binds to the active site
ligand of CA-IX and also binds to CAXII. Wepropose to evaluate 18F-VM4-037 as a PET
radiopharmaceutical for the in vivo detection of CA-IX and CAXII in renal tumors.
- To evaluate the biodistribution of 18F-VM4-037 within tumor and non-tumor tissues.
- To assess safety of 18F-VM4-037 in patients with primary or metastatic RCC.
- Subject is greater than or equal to 18 years old, ECOG 0-2.
- Subject must have confirmed primary RCC (greater than or equal to 2.5cm) in diameter on
conventional imaging modality or extrarenal/extrahepatic RCC lesion (greater than or
equal to 1cm).
- Twenty subjects with primary RCC greater than or equal to 2.5cm in diameter or
extrarenal/extrahepatic lesion suspicious for metastatic RCC (greater than or equal to 1cm
in diameter) scheduled for clinically indicated surgery or biopsy will undergo dynamic
18F-VM4-037 PET/CT imaging. Results will be compared with pathology.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Quantitative measurements of the level of uptake of 18F-VM4-037 in tumor and non tumor tissues, calculated as SUVs
Adam R Metwalli, M.D.
National Cancer Institute (NCI)
United States: Federal Government
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