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

NCT07084909 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2025-12-10

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Lantheus Medical Imaging

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2027-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07084909 on ClinicalTrials.gov