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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
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
时间窗: 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.
次要结局
未报告次要终点