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

NCT02233621 | Terminated Phase 2

• 2 other identifiers: 49RC10_32_01-PHRC2010-022011-003734-14
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Within 3 months after inclusion when laparoscopy is already scheduled.

Study Arms (1)

PET with [18F]-FES

EXPERIMENTAL

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

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

Interventions

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

PET with \[18F\]FES before coelioscopy

Also known as: analog of estrogene

PET with [18F]-FES

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Nuclear medicin unit, University Hospital of Angers

Angers, 49933, France

Location

MeSH Terms

Conditions

Endometriosis

Interventions

16-fluoroestradiol

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Philippe Descamps, PU-PH

  University Hospital of Angers

  STUDY CHAIR

• Olivier Couturier, PU-PH

  University Hospital of Angers

  PRINCIPAL INVESTIGATOR

• Céline Lefebvre-Lacoeuille, PH

  University Hospital of Angers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 8, 2014
• Study Start: June 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: April 6, 2016
• Last Updated: September 17, 2018

Record last verified: 2014-09

Locations

FR (1)