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

Endometriosis Clinical Trial

— ENDOTEP  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02233621
• Other study ID #: 49RC10_32_01-PHRC2010-02
• Secondary ID: 2011-003734-14
• Status: Terminated
• Phase: Phase 2
• Start date: June 2012
• Est. completion date: April 6, 2016

Study information

• Verified date: September 2014
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: April 6, 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Other:
• [18F]FES (16a-[18F]Fluoro-17ß-estradiol)
PET with [18F]FES before coelioscopy

Locations

Country	Name	City	State
France	Nuclear medicin unit, University Hospital of Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.