Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer
Conditions
Metastatic Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
PET/CT,fluoroestradiol (18F), breast cancer, metastatic, prediction of response, hormone therapy
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Fluoroestradiol (18F)
Type: Drug
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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- Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment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)
Location
Service de Médecine Nucléaire, Hôpital Tenon
Paris, France
Status: Recruiting
Contact: Khaldoun KERROU, MD - 33 1 56 01 67 98 - Khaldoun.kerrou@tnn.aphp.fr
Start Date
June 2012
Completion Date
June 2015
Sponsors
Assistance Publique - Hôpitaux de Paris
Source
Assistance Publique - Hôpitaux de Paris
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page