NCT07084909

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

Phase 2/3 Open-Label Multicenter Study to Assess the Diagnostic Performance of Piflufolastat F 18 PET/CT on Intended Clinical Management in Patients With Suspected, or at High Risk for Metastatic ccRCC

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Lantheus Medical Imaging · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is an adaptive Phase 2/3, open-label, multi-center, single-arm study designed to evaluate diagnostic performance of piflufolastat F 18 PET/CT in the staging of patients suspected of having, or who are at high risk for, metastatic ccRCC and its impact on intended clinical management.

Conditions

• Clear Cell Renal Cell Carcinoma

Interventions

Type	Name	Description
DRUG	piflufolastat F 18	18F-DCFPyL is a fluorine-18 radiolabeled low molecular weight positron emission tomography (PET) tracer that binds to the extracellular domain of prostate-specific membrane antigen (PSMA) with high affinity.

Timeline

• Start date: 2025-11-01
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-07-25
• Last updated: 2025-12-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study