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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003601-21 | EudraCT Number | ||
| 2024-517400-11-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| Simbec-Orion Group | INDUSTRY |
| Keosys | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective population | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F Fluoroestradiol Radiopharmaceutical with PET/CT | Drug | Administration of one dose of 18F FES for PET/CT imaging |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Change from baseline therapeutic measure at 15 days after ESTROTEP PET/CT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Cochet | Centre Georges Francois Leclerc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CGFL | Dijon | 21079 | France | |||
| CHU Grenoble Alpes |
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| La Tronche |
| 38700 |
| France |
| CHU de Limoges - Dupuytren | Limoges | 87000 | France |
| Centre Léon Bérard | Lyon | 69008 | France |
| Institut du Cancer de Montpellier | Montpellier | 34298 | France |
| Hôpital Américain de Paris | Neuilly-sur-Seine | 92200 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Hôpital Tenon | Paris | 75020 | France |
| Institut Curie | Paris | 75248 | France |
| Institut Curie | Saint-Cloud | 92210 | France |
| Institut Claudius Regaud Centre de Lutte Contre le Cancer | Toulouse | 31059 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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