Endometriosis
Conditions
Brief 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.
Interventions
OTHER[18F]FES (16α-[18F]Fluoro-17β-estradiol)
PET with \[18F\]FES before coelioscopy
Sponsors
University Hospital, Angers
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
France
Outcome results
None listed