drugset / Trial / NCT05486182

Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer

NCT05486182

Phase 4 Active not recruiting 153 enrolled GE Healthcare Keosys · collabSimbec-Orion Group · collab
NaSingle-groupOpen-labelDiagnostic

Summary

This is a multi-center study in France to evaluate the impact of ESTROTEP PET/CT results on the therapeutic management of patients with metastatic breast cancer (MBC). Each patient will be screened to determine whether the patient meets all the inclusion criteria and none of the exclusion criteria. After inclusion, a standardized pre ESTROTEP PET/CT questionnaire will be completed by the investigators to evaluate the initial management plan. Patient will perform the ESTROTEP PET/CT examination at visit 2. A standardized post ESTROTEP PET/CT questionnaire will then be completed by the investigators. Patients will be followed for 12 months to evaluate their clinical status and standard of care investigations.

Timeline

Start
2022-02-08
Primary completion
2025-04-18
Completion
2026-01

Drugs

EvaluationDrugModalityDoseRoute
Subject F-18 16 Alpha-Fluoroestradiol Diagnostic / imaging agent

Indications