Clinical Trial · NCT07084909

An Adaptive Phase 2/3 Open-Label Multicenter Study to Assess the Diagnostic Performance of Piflufolastat F 18 PET/CT and Its Impact on Intended Clinical Management in Patients with Suspected, or at High Risk for, Metastatic Clear Cell Renal Cell Carcinoma.

Overview

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.

Sponsor

Lantheus Medical Imaging

Phase

Phase 2/3

Contacts

Vicki White (Clinical Trial Lead)

clinicaltrials@lantheus.com

978-671-8886

ClinicalTrials.gov

NCT07084909

Eligibility

Inclusion

ECOG 0-2 and life expectancy of at least 6 months
Completed staging evaluation with conventional imaging within 60 days prior to Study Day 1
Adults with ccRCC with at least 1 metastatic lesion (Ph 2) and suspected or high risk for metastatic disease (Ph 3)

Exclusion

Any unresolved active malignancy within past 3 years; any condition (e.g. dialysis) compromising safety/compliance
High energy (>300 KeV) gamma-emitting radioisotope within five (5) physical half-lives, prior to Day 1
Expected to receive anti-cancer treatment between baseline imaging, piflufolastat F 18 PET/CT, biopsy/surgery
Active systemic therapy prior to Day 1; 30-day (12 wks for immunotherapy) washout required from last therapy
Prior imaging with girentuximab or any PSMA-PET agent or any non-approved ccRCC imaging agent within the last 3-months

Patient Education

Patient education not yet provided.

Publications

Publications not yet provided.

Locations

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