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临床试验/NCT03186820
NCT03186820已完成不适用

Exploratory Study of the Interest of MRI Susceptibility Weighted Imaging for the Pre-operative Assessment of Pelvic Endometriosis Extent

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2017年6月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74
试验地点
2
主要终点
Interest of MRI Susceptibility Weighted Imaging

研究概览

简要总结

Knowledge of the precise location of endometriosis is essential for a successful surgical treatment. MRI Susceptibility-Weighted Imaging (SWI-MRI) yields high sensitivity for blood by-products detection. Since endometriosis lesions are haemorrhagic, and therefore rich in blood by-products such as hemosiderin, SWI-MRI could be useful in the pre-operative assessment of endometriosis, especially in superficial peritoneal lesion detection. The purpose of our study is to evaluate the performance of SWI-MRI for the preoperative work-up of endometriosis

详细描述

Pelvic endometriosis is a cause of pelvic pain, dysmenorrhea, urinary symptoms and infertility. MRI is considered as the best imaging technique to detect and to predict the extent of the disease. Susceptibility Weighted Imaging is routinely performed to identify haemorrhagic lesions in brain MRI protocols and has proven to be a sensitive technique to detect blood by-products. A pelvic MRI protocol including SWI will be performed in all women addressed for diagnostic assessment or pre-operative work-up of endometriosis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
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

入选标准

  • Adult woman (over 18yrs old) addressed for diagnostic assessment or pre-operative work-up of endometriosis;
  • Informed signed consent
  • Affiliated or beneficiary of a social security system

排除标准

  • Patient <18yrs old
  • Pregnant or nursing woman
  • Patient under legal protection
  • Contraindication to MRI

研究组 & 干预措施

SWAN sequence

Experimental

Susceptibility Weighted Imaging as 3D SWAN sequence

干预措施: Susceptibility Weighted Imaging as 3D SWAN sequence (Other)

结局指标

主要结局

Interest of MRI Susceptibility Weighted Imaging

时间窗: Baseline (MRI) and day of surgery

The diagnostic use of SWI-MRI will be assessed through: * the number of endometriotic locations, which are both identified with SWI-MRI and confirmed by surgery. * the sensitivity, specificity, and predictive values of MRI. * signal intensities of each endometriotic location found in surgery on T1 weighted sequence (presence of a high signal intensity) and SWI (presence of a low signal intensity)

次要结局

  • Deep forms of endometriosis(Baseline (MRI) and day of surgery)
  • Superficial forms of endometriosis(Baseline (MRI) and day of surgery)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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