Exploratory Study of 18FPT2385 PETCT Imaging to Measure HIF2lpha in Patients with Renal Cell Carcinoma including Metastatic and Von Hippel-Lindau Syndrome Cases

What this Trial Is About

This research aims to evaluate the use of an investigational imaging agent called 18FPT2385 in patients with renal cell carcinoma RCC, including clear cell RCC and those with Von Hippel-Lindau VHL syndrome. The study is designed to explore how well this imaging method can measure levels of a protein called hypoxia-inducible factor-2alpha HIF2b1 in tumors, which is important for understanding the disease. It is an open-label, non-therapeutic trial involving three patient groups with different disease presentations. Participants will receive an intravenous injection of 18FPT2385 followed by PETCT or PETMRI scans to observe the distribution and uptake of the tracer in tumors. The first group consists of patients scheduled for surgery, who will have imaging before nephrectomy, with results compared to tissue analysis after surgery. The second group includes patients with metastatic clear cell RCC, who will have imaging and a mandatory biopsy of metastatic sites. The third group involves patients with VHL syndrome and various tumors, who will undergo imaging and are encouraged, but not required, to have a biopsy. Some participants may have repeat imaging after initial dosimetry assessments. Throughout the study, patients will undergo multiple imaging sessions, including dynamic and whole-body scans at different time points after tracer injection to analyze tracer kinetics and distribution. Researchers will collect tissue samples for comparison with imaging findings, and participants will continue with standard or experimental treatments as advised by their doctors. The study aims to correlate imaging results with tissue levels of HIF2b1 over up to five years, monitoring safety and feasibility during the process.

[18F]PT2385 PET/CT in Patients With Renal Cell Carcinoma