drugset / Trial / NCT07084909

Piflufolastat F 18 PET/CT in Patients With Suspected, or at High Risk for Metastatic ccRCC

NCT07084909

Phase 2/3 Withdrawn Lantheus Medical Imaging
Non-randomizedSequentialOpen-labelDiagnostic

Summary

This study is being conducted to test whether an imaging technique called a "piflufolastat F 18 PET/CT" imaging scan can be used to diagnose and describe the extent of clear cell Renal Carcinoma in patients. The main questions it aims to answer are: * What is the most appropriate dose and scan timing window for piflufolastat F 18 PET/CT for patients with clear cell Renal Cell Carcinoma (ccRCC) with known metastatic disease? * Ability of piflufolastat F 18 PET/CT to detect metastatic of lesions ccRCC in patients with suspected metastatic disease and those at high risk for metastatic disease (the cancer has spread beyond the kidney) and impact of the imaging on clinical management of the kidney cancer? Participants will: * Receive a single injection of piflufolastat F 18 injection followed by imaging scans. * Be contacted via telephone to ask about any reactions or discomforts they may have after the piflufolastat F 18 injection. * May be followed for up to 6 months to collect data about disease progression.

Timeline

Start
2025-11
Primary completion
2027-09
Completion
2027-09

Drugs

EvaluationDrugModalityDoseRoute
Subject 18F-DCFPyL Diagnostic / imaging agent 9 unknown