Clinical trial NCT02233621: Assessment of Performance of [18F]-FES for Endometriosis Diagnosis
Official title: Evaluation Des Performances de la Tomographie Par Emission de Positons Avec la 16α-[18F]Fluoro-17β-estradiol ([18F]-FES) Pour le Diagnostic de l'Endometriose
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Endometriosis
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2014-09-08
Enrollment: 31
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: Within 3 months after inclusion when laparoscopy is already scheduled.
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Nuclear medicin unit, University Hospital of Angers
Study officials:
affiliation: University Hospital of Angers
name: Philippe Descamps, PU-PH
role: STUDY_CHAIR
affiliation: University Hospital of Angers
name: Olivier Couturier, PU-PH
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Angers
name: Céline Lefebvre-Lacoeuille, PH
role: PRINCIPAL_INVESTIGATOR
References: