Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IDRCB | Other Identifier | 2011/005043-27 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline. Hypothesis: best response rate will be observed in patients with all metastases taking up FES prior to treatment.
Main objective: Compare the response rate after 6 months of hormone treatment (or a major change in hormone treatment) in metastatic breast cancer, according to the uptake of FES in metastatic lesions taking-up FDG on PET/CT at baseline.
Secondary objectives:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluoroestradiol (18F) | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoroestradiol (18F) | Drug | 2-4 MBq/kg body mass, one single IV injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response rate six months after induction or major change in hormone therapy for metastatic breast cancer. | Response rate six months after induction or major change in hormone therapy for metastatic breast cancer. Response will be determined according to RECIST 1.1 criteria for each patient. | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of visible non-physiologic foci on FES PET and on the corresponding FDG PET, during centralised reading sessions by masked readers. | at 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Khaldoun KERROU, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Médecine Nucléaire, Hôpital Tenon | Paris | 75020 | France |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 18, 2022 | |
| Reset | Jun 2, 2023 | |
| Release | Jul 2, 2025 | |
| Reset | Jul 21, 2025 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 18, 2022 | Jun 2, 2023 | |||
| Jul 2, 2025 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Jul 21, 2025 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |