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piflufolastat F 18 · HARRIER

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

Ensayo de Lantheus Holdings, Inc. en Carcinoma de celulas renales de celulas claras.

Más ensayos de: Carcinoma renal de células claras.

Fase

Fase 2/3

Estado

Retirado antes de empezar

Centros

2

Fin del objetivo primario

sep 2027

estimado por el promotor

Qué significa cada fase y cada estado.

Estudio de intervención, no aleatorizado, abierto. Comenzó en nov 2025.

Este ensayo se detuvo. Motivo declarado por el promotor (del registro, en inglés): «Operational challenges in patient enrollment».

Qué mide

Objetivo primario de la Fase 2 - Establecer la dosis optima y la ventana temporal de piflufolastat F18 para la deteccion de enfermedad metastasica (On Day 1 (day of injection) where Piflufolastat F18 will be administered at a target dose of 9 mCi [+/-1 mCi]) after which patients will be scanned at 60-90 minutes and again at 3-4 hours.) (del registro, en inglés)

Qué se prueba

Cómo lo describe el promotor

En el documentoEn inglés, del registroThis 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.

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Todos los de LNTH, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT07084909), actualizada en dic 2025.