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

NCT05486182 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2025-08-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

18F Fluoroestradiol Radiopharmaceutical with PET/CT

Administration of one dose of 18F FES for PET/CT imaging

Sponsors & Collaborators

  • Simbec-Orion Group

    collaborator INDUSTRY
  • Keosys

    collaborator UNKNOWN
  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Alexandre Cochet · Centre Georges Francois Leclerc

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2025-04-18
Completion
2026-01-31

Countries

  • France

Study Locations

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Entities

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 NCT05486182 on ClinicalTrials.gov