Assessment of Performance of [18F]-FES for Endometriosis Diagnosis (ENDOTEP)
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|ClinicalTrials.gov Identifier: NCT02233621|
Recruitment Status : Terminated (not enough enrollement)
First Posted : September 8, 2014
Last Update Posted : September 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis||Other: [18F]FES (16α-[18F]Fluoro-17β-estradiol)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||June 2012|
|Actual Primary Completion Date :||April 2016|
|Study Completion Date :||April 6, 2016|
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 Name: analog of estrogene
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02233621
|Nuclear medicin unit, University Hospital of Angers|
|Angers, France, 49933|
|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|