Prospective, Multicenter Study Evaluating the Diagnostic Performance of the 3DT1 Sequence in Magnetic Resonance Imaging for Superficial Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Correlation between the diagnosis of superficial endometriosis by the 3DT1 sequence in Magnetic Resonance Imaging and the histology obtained by laparoscopy
研究概览
简要总结
The purpose of the study is to determine the correlation between the diagnosis of Superficial endometriosis by the 3DT1 sequence on Magnetic resonance imaging and the histology obtained by laparoscopy.
详细描述
This is a prospective, multicenter, non-randomized study evaluating the diagnostic performance of Magnetic Resonance Imaging in superficial endometriosis.
The duration of the patient's participation in the study is a maximum of 15 months depending on the length of the screening period and the time between Magnetic Resonance Imaging and laparoscopy.
After selection, the investigator will check the patient's eligibility and offer her the study. If she accepts and signs the informed consent form, the patient will have an exploratory pelvic Magnetic Resonance Imaging lasting approximately 15 to 20 minutes, without systematic injection of contrast product.
After Magnetic Resonance Imaging, the patient will benefit from a laparoscopy under general anesthesia lasting an average of one hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years;
- •Non-menopausal patient;
- •Patient scheduled for exploratory laparoscopy;
- •Patient requiring a preoperative pelvic MRI
- •Patient having been informed and having signed an informed consent form.
排除标准
- •Classic contraindications to magnetic resonance imaging;
- •Contraindications to anesthesia for exploratory laparoscopy;
- •Contraindication to surgery following the findings of magnetic resonance imaging results;
- •Patient with endometrioma > 4 cm;
- •Patient with known deep endometriosis;
- •Patient uncooperative with protocol requirements or unable to attend the center for scheduled visits;
- •Pregnant woman or woman of childbearing age, without effective contraception or breastfeeding;
- •Patient participating in another clinical trial, or during a period of exclusion from another clinical trial;
- •Patient under guardianship, under curatorship or subject to legal protection, persons deprived of liberty by a judicial or administrative decision, persons subject to psychiatric care and admitted to a health or social establishment;
- •Patient not beneficiary of a social security system
- •Patient under State Medical Aid.
结局指标
主要结局
Correlation between the diagnosis of superficial endometriosis by the 3DT1 sequence in Magnetic Resonance Imaging and the histology obtained by laparoscopy
时间窗: between 30 and 150 days
The diagnostic validity of Magnetic resonance imaging compared to laparoscopy will be determined by correlation between the locations of the sites screened on Magnetic resonance imaging (Douglas cul de sac, vesicouterine cul de sac, right ovarian fossa, left ovarian fossa, right broad ligament, left broad ligament) and histologically confirmed endometriotic implants at these sites.
次要结局
未报告次要终点