Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer (ESTROTEPREDIC)
This study is currently recruiting participants.
Verified September 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01627704
First received: June 14, 2012
Last updated: September 6, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Metastatic Breast Cancer |
Drug: Fluoroestradiol (18F) |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 16α-[18F]-Fluoro-œstradiol PET: an in Vivo Biomarker Predicting Response to Hormone Treatment of Metastatic Breast Cancer? |
Resource links provided by NLM:
Further study details as provided by Assistance Publique - Hôpitaux de Paris:
Primary Outcome Measures:
- Response rate six months after induction or major change in hormone therapy for metastatic breast cancer. [ Time Frame: at 6 months ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Number of visible non-physiologic foci on FES PET and on the corresponding FDG PET, during centralised reading sessions by masked readers. [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 72 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Fluoroestradiol (18F)
NA
|
Drug: Fluoroestradiol (18F)
2-4 MBq/kg body mass, one single IV injection
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Post menopausal
- age > 17
- WHO 0-2
- Metastatic adenocarcinoma of the breast
- Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment
- Life expectancy > 6 months
- Hormone-dependent cancer initially demonstrated by hormone receptors in the tumour
- Presence of oestrogen receptors proven with immunohistochemistry (> 10%) and HER2 determined by immunohistochemistry or FISH (on primary tumour or a metastasis)
- Metastatic recurrence on FDG PET dating less than 1 month, confirmed by another modality (contrast-enhanced CT, MRI, ultrasonography, bone scintigraphy or PET/CT, other)
- FDG PET/CT available on PACS or CD DICOM III format 11
- Informed consent obtained
Exclusion Criteria:
- Other evolutive malignant disease or acute or chronic infectious disease
- Chemotherapy during the last 3 months or change in treatment since FDG PET/CT.
- Isolated liver metastasis (high FES uptake by normal liver)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01627704
Contacts
| Contact: Khaldoun KERROU, MD | 33 1 56 01 67 98 | Khaldoun.kerrou@tnn.aphp.fr |
| Contact: Jean-Noël TALBOT, MD-PHD | Jean-noel.talbot@tnn.aphp.fr |
Locations
| France | |
| Service de Médecine Nucléaire, Hôpital Tenon | Recruiting |
| Paris, France, 75020 | |
| Contact: Khaldoun KERROU, MD 33 1 56 01 67 98 Khaldoun.kerrou@tnn.aphp.fr | |
| Contact: Jean-Noël TALBOT, MD, PhD Jean-noel.talbot@tnn.aphp.fr | |
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
| Principal Investigator: | Khaldoun KERROU, MD | Assistance Publique - Hôpitaux de Paris |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01627704 History of Changes |
| Other Study ID Numbers: | P110113, IDRCB |
| Study First Received: | June 14, 2012 |
| Last Updated: | September 6, 2012 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
PET/CT,fluoroestradiol (18F) breast cancer metastatic prediction of response hormone therapy |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013