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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-04-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Endometriosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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PET with [18F]-FES

PET with \[18F\]-FES compared to histological analysis performed at least on one biopsy done during coelioscopy.

Group Type EXPERIMENTAL

[18F]FES (16α-[18F]Fluoro-17β-estradiol)

Intervention Type OTHER

PET with \[18F\]FES before coelioscopy

Interventions

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[18F]FES (16α-[18F]Fluoro-17β-estradiol)

PET with \[18F\]FES before coelioscopy

Intervention Type OTHER

Other Intervention Names

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analog of estrogene

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No