A Phase 4 interventional study of 18F Fluoroestradiol Radiopharmaceutical with PET/CT in Metastatic Breast Cancer, sponsored by GE Healthcare. Active, not recruiting at 11 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by GE Healthcare · Phase 4, Interventional, and Diagnostic
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 153 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →GE Healthcare is the lead sponsor of 168 studies on the registry; 19 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 16 (89%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: 18F Fluoroestradiol Radiopharmaceutical with PET/CT
Administration of one dose of 18F FES for PET/CT imaging
Also known as: ESTROTEP
To assess the impact of ESTROTEP PET/CT on metastatic breast cancer patients management, initially ER+ and HER2-, in relapse after first-line treatment combining hormone therapy.
The percentage of patients for whom a substantial therapeutic measure was implemented following an analysis of the FES PET examination. This assessment will be performed prospectively by means of a standardised questionnaire completed by the prescribing clinician, when the request for an FES PET/CT is made. The therapeutic modality initially planned and the modality actually used may be determined by a multidisciplinary consultation meeting depending on the centre. This questionnaire will completed again within a maximum period of 15 days following the FES PET/CT in order to specify the final therapeutic measure. Substantial measures will be considered to be any major modifications made in terms of: therapeutic modalities, diagnostic modalities and follow-up modalities.
Time frame: Change from baseline therapeutic measure at 15 days after ESTROTEP PET/CT
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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