2024-520423-88-00招募中3 期
Contribution of PET (positron emission tomography) scans for the preoperative assessment of symptomatic endometriosis lesions: TEP-ENDORUN
Centre Hospitalier Universitaire De La Reunion1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年1月29日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Total number of endometriosis lesions diagnosed by PET scan in our 10 patients compared with the number of lesions described during surgery.
研究概览
简要总结
To assess the PET scan in the diagnosis of endometriosis lesions compared to surgery in terms of number of lesions diagnosed and locations.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 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
- •Patient showing at least one typical endometriosis lesion on MRI, greater than 5mm
- •Patient accepting surgical management
- •Patient having signed an informed consent after information
- •Patient 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)
- •Use of corticosteroids and anti-inflammatory drugs within 7 days prior to PET scan For patients with a chronic pathology requiring long-term treatment with corticosteroids and/or use of corticosteroids and anti-inflammatory drugs within 7 days prior to PET scan
- •Blood glucose > 1.6 g/L e on day of PET Scanner
- •Patient with a history of heavy abdominopelvic surgery
- •Diabetic patient
- •Patient with contraindication to surgery or anesthesia
- •Patient unable to understand the interest of the study
- •Patient with 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.)
- •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)
- •Positive plasma HCG assay in the days preceding the PET scan;
结局指标
主要结局
Total number of endometriosis lesions diagnosed by PET scan in our 10 patients compared with the number of lesions described during surgery.
Total number of endometriosis lesions diagnosed by PET scan in our 10 patients compared with the number of lesions described during surgery.
Number of locations identified by PET scan compared with number of locations identified during surgery.
Number of locations identified by PET scan compared with number of locations identified during surgery.
次要结局
- SUV threshold to identify endometriosis lesions.
- Number of lesions visible on PET scan and not visible on MRI, location on PET scan compared with MRI
研究者
TRAN
Scientific
Centre Hospitalier Universitaire De La Reunion
研究点 (1)
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