NCT04831619已完成3 期
Contribution of PET Scans for the Preoperative Assessment of Symptomatic Endometriosis Lesions: TEP-ENDORUN
Centre Hospitalier Universitaire de la Réunion4 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年12月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 4
- 主要终点
- To assess the PET scan in the diagnosis of endometriosis lesions compared to surgery in terms of number of lesions diagnosed and locations.
研究概览
简要总结
Endometriosis is an inflammatory condition that is often treated by surgery. MRI and ultrasound are used for the preoperative morphological assessment. Currently, only surgery allows the exhaustive and qualitative diagnosis of lesions.
The PET scan, fixing in certain inflammatory pathologies and in certain cases of endometriosis, could refine this assessment by evaluating the location of the lesions.
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
- •Patient aged over 18 and under 50
- •Patient with symptomatic endometriosis with indication for surgery
- •Showing at least one typical endometriosis lesion on MRI, greater than 5mm
- •Accepting surgical management
- •Having signed an informed consent after information
- •Affiliate or beneficiary of a social security scheme
排除标准
- •Patient who has received an injection with GnRH (gonadotropin-releasing hormone ) analogues for less than 3 months (because it induces the quiescence of the disease which is no longer stimulated by estrogen secretion)
- •Patient with a history of heavy abdominopelvic surgery
- •Diabetic patient
- •Patient unable to understand the interest of the study
- •Patient already included in another therapeutic trial with an experimental molecule.
- •Persons referred to in articles L1121-5 to L1121-8 of the PHC (public health code) (corresponding to all protected persons: pregnant woman, parturient, nursing mother, person deprived of liberty by judicial or administrative decision, minor, and person making the subject to a legal protection measure: guardianship or curators)
- •Contraindications to PET Scanner (major claustrophobia, contraindication or hypersensitivity to 18-FDG or one of its excipients, contraindication or hypersensitivity to Ultravist® or one of its excipients, etc.)
- •Contraindication to surgery or anesthesia
研究组 & 干预措施
PET scanner in addition to MRI
Experimental
干预措施: PET scanner with injection of 18 FDG (18F-2-fluoro-2-deoxy-D-glucose) (radiolabel) (Drug)
结局指标
主要结局
To assess the PET scan in the diagnosis of endometriosis lesions compared to surgery in terms of number of lesions diagnosed and locations.
时间窗: at inclusion (before surgery)
Total number of endometriosis lesions diagnosed by the PET scanner
次要结局
- Define a reading threshold of SUV (Standardized Uptake Value) on a PET scanner for the diagnosis of endometriosis(up to 14 weeks (after PET-Scanner))
- Compare the results of the PET scanner and MRI for the sensitivity of detection of endometriosis lesions(up to 14 weeks (after surgery))
研究者
研究点 (4)
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