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

University Hospital, Angers

Status and phase: Terminated; Phase 2

Conditions: Endometriosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02233621

49RC10_32_01-PHRC2010-02

2011-003734-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

PET with [18F]-FES

Experimental group

Description:

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

Treatment:

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