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

NCT02233621 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-09-17

No results posted yet for this study

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

Interventions

OTHER

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

PET with \[18F\]FES before coelioscopy

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Principal Investigators

  • Philippe Descamps, PU-PH · University Hospital of Angers

  • Olivier Couturier, PU-PH · University Hospital of Angers

  • Céline Lefebvre-Lacoeuille, PH · University Hospital of Angers

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-04-30
Completion
2016-04-06

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02233621 on ClinicalTrials.gov