NCT02233621

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University Hospital, Angers · Other Government
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
OTHER	[18F]FES (16α-[18F]Fluoro-17β-estradiol)	PET with \[18F\]FES before coelioscopy

Timeline

• Start date: 2012-06-01
• Primary completion: 2016-04-01
• Completion: 2016-04-06
• First posted: 2014-09-08
• Last updated: 2018-09-17

Locations

1 site across 1 country: France