Assessment of Performance of [18F]-FES for Endometriosis Diagnosis

Phase 2

Terminated

• Conditions: Endometriosis
• Interventions: Other: [18F]FES (16α-[18F]Fluoro-17β-estradiol)

• Registration Number: NCT02233621
• Lead Sponsor: University Hospital, Angers

Brief Summary

Endometriosis is a benign chronic disease responsible for infertility and pelvic pain. One of the main problem of endometriosis is the significant delay of diagnosis.This delay has significant consequences for patients. Currently the definitive diagnosis of endometriosis and the evaluation of its lesional extension require performing laparoscopy and a histological analysis of biopsy and pathologic areas. Lesions of endometriosis whose development and growth are estrogen-dependent, express estrogen receptor (ER). \[18F\]FES (16α-\[18F\]Fluoro-17β-estradiol) is an analog of estrogen, used in positron emission tomography (PET), and a specific tracer of ER. We propose to evaluate the performance of this functional imaging as a diagnostic tool for endometriosis.

The aim of this multicenter, prospective, open study is to assess sensitivity of PET with \[18F\] -FES for diagnosing endometriosis compared to the gold standard (histological confirmation on biopsy or excision of lesions performed during laparoscopy) in women care for suspected endometriosis and for whom laparoscopy is already scheduled.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2014-08-29
• Status Verified: 2014-09
• Study First Submitted QC: 2014-09-03
• Study First Posted: 2014-09-08
• Primary Completion: 2016-04
• Study Completion: 2016-04-06
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 31

Inclusion Criteria

• First planned coelioscopy (therapeutic indication) for suspected endometriosis
• Patient aged from 18 to 50 years
• Absence of treatment with GnRH (gonadotropin-releasing hormone) analogue for at least 3 months
• Patient affiliated to a social security system
• No hormonal treatment for at least 3 months

Exclusion Criteria

• History of abdominal pelvic surgery for endometriosis
• Current treatment with GnRH (gonadotropin-releasing hormone) or stopped for less than 3 months
• hormonal Drug ongoing
• Patient pregnant, may be or during lactation
• Patient under guardianship or trusteeship
• Patient unable to understand the purpose of the study
• Patient already included in another clinical trial with an experimental molecule.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET with [18F]-FES	[18F]FES (16α-[18F]Fluoro-17β-estradiol)	PET with \[18F\]-FES compared to histological analysis performed at least on one biopsy done during coelioscopy.

Primary Outcome Measures

Name	Time	Method
sensitivity of PET with [18F] -FES for diagnosing endometriosis defined by the ability of this diagnostic exam to give a positive result when endometriosis is present	Within 3 months after inclusion when laparoscopy is already scheduled.	PET with \[18F\]-FES considered positive if it allows to identify at least one hyperfixation area in a physiologically area not fixing tracer or not corresponding to a physiological removal area tracer.; PET results will be correlated with The results of PET with \[18F\] -FES will be correlated with histology results of at least one of the biopsies performed at laparoscopy.

Trial Locations

Locations (1)

Nuclear medicin unit, University Hospital of Angers; 🇫🇷 Angers, France