Fluoroestradiol PET Imaging in Predicting Response to Hormone Therapy of Breast Cancer

NCT ID: NCT01627704

Last Updated: 2015-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2015-01-31

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

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fluoroestradiol (18F)

Group Type: OTHER

Fluoroestradiol (18F)

Intervention Type: DRUG

2-4 MBq/kg body mass, one single IV injection

Interventions

Fluoroestradiol (18F)

2-4 MBq/kg body mass, one single IV injection

Intervention Type: DRUG

Eligibility 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• Treated by antihormone treatment during around 5 years withdrawn for at least 3 months OR metastatic cancer at diagnosis having received no more than one line of hormone treatment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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Khaldoun KERROU, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service de Médecine Nucléaire, Hôpital Tenon

Paris, , France

Countries

France

Other Identifiers

IDRCB

Identifier Type: OTHER

Identifier Source: secondary_id

P110113

Identifier Type: -

Identifier Source: org_study_id