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

September 13, 2018 updated by: University Hospital, Angers

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • Nuclear medicin unit, University Hospital of Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PET with [18F]-FES
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)
PET with [18F]FES before coelioscopy
Other Names:
  • analog of estrogene

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Within 3 months after inclusion when laparoscopy is already scheduled.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Investigators

  • Study Chair: Philippe Descamps, PU-PH, University Hospital of Angers
  • Principal Investigator: Olivier Couturier, PU-PH, University Hospital of Angers
  • Principal Investigator: Céline Lefebvre-Lacoeuille, PH, University Hospital of Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

April 1, 2016

Study Completion

April 6, 2016

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

September 3, 2014

First Posted (Estimate)

September 8, 2014

Study Record Updates

Last Update Posted (Actual)

September 17, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49RC10_32_01-PHRC2010-02
  • 2011-003734-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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