Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-25 @ 7:04 PM
Study NCT ID:
NCT01627704
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
2012-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
16α-[18F]-Fluoro-œstradiol PET: an in Vivo Biomarker Predicting Response to Hormone Treatment of Metastatic Breast Cancer?
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESTROTEPREDIC
Brief Summary:
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.
Detailed Description:
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:
* evaluate diagnostic performance of FES PET/CT
* determine whether FES PET/CT is able to detect metastases that are not visible on FDG PET/CT. This point may constitute a direct benefit for the patient
* precise the nature of discordant FES/FDG foci
* validate and improve the interpretation criteria for FES PET/CT
* confirm the perfect tolerance
Secondary objectives:
* evaluate diagnostic performance of FES PET/CT
* determine whether FES PET/CT is able to detect metastases that are not visible on FDG PET/CT. This point may constitute a direct benefit for the patient
* precise the nature of discordant FES/FDG foci
* validate and improve the interpretation criteria for FES PET/CT
* confirm the perfect tolerance
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IDRCB | OTHER | 2011/005043-27 | View |