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临床试验/NCT06577831
NCT06577831已完成不适用

Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年2月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Develop new three-dimensional analysis tools combining high spatial resolution static MRI with ultra-fast dynamic MRI.

研究概览

简要总结

Pelvic floor disorders affect a large population of women and are responsible for a significant impairment in their quality of life, but the pathophysiology of these disorders is still poorly understood.

The project proposes to define new ultra-fast 3D MRI sequences to capture the movements of the main pelvic organs. Visualization of 3D volumes is of great importance to clinicians, but data size hinders clinical use.

This study is the first to propose a dynamic 3D representation of pelvic organs, together with quantitative estimates of the deformations undergone.

The method is based on four steps: dynamic acquisition, organ segmentation, temporal reconstruction, quantification and visualization of deformations.

The D3-Pelvis project responds to the challenge of "technologies for health" with dynamic 3D MRI acquisition and 3D modeling, offering prospects for diagnostic aids and simulators.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
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 women, +/- of childbearing age, with or without effective contraception.
  • Informed consent signed prior to any procedure described in the study.

排除标准

  • Contraindication to MRI,
  • Impossibility of performing the examination during thrust,
  • Minor patients
  • Pregnant or breast-feeding women,
  • Women of legal age under guardianship
  • Persons staying in a health or social institution,
  • People in emergency situations,
  • Persons not covered by a social security scheme,
  • Persons deprived of their liberty.
  • Specifically, women with IUDs will be excluded if they cannot remove them before the examination.
  • For healthy volunteers: history of colorectal surgery.

结局指标

主要结局

Develop new three-dimensional analysis tools combining high spatial resolution static MRI with ultra-fast dynamic MRI.

时间窗: 0 month

a metric for displacement of the anchor points of the targeted pelvic organs will be evaluated

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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