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临床试验/NCT02582346
NCT02582346已完成不适用

Assessment of Magnetic Resonance Imaging Neurography and Tractography for Preoperative Mapping of Pelvic Nerves

IHU Strasbourg2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2015年11月1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
20
试验地点
2
主要终点
Assessment of image quality to delineate and identify nerves

研究概览

简要总结

This project aims at assessing two MRI acquisition methods, neurography and tractography, for the visualization of pelvic nerves. The goal is to optimize both methods and to test them on a pool of volunteers to assess if nerves can be delineated, so as to provide an individualized mapping of nerves to surgeons before an intervention and avoid postoperative complications.

详细描述

Nerves of the autonomic nervous system are frequently damaged during pelvic surgery, and those injuries may lead to postoperative complications like incontinence or impotence. This study aims at developing an imaging protocol providing images where nerves can be visualized and segmented. A simple preoperative MRI exam might yield an individualized mapping of pelvic nerves that would be combined to augmented reality, thereby providing a valuable support to guide surgeons during an intervention by indicating location of the nerves that have to be preserved.

Up to now, investigations have been carried out with a 1.5 Tesla (1.5T) MRI system on an animal model (pig). MRI is non irradiant and non invasive imaging modality that proved to be a valuable method to visualize small structures like nerves. Investigations focused on MRI neurography, an anatomical imaging method highlighting nerves, and MRI tractography, a diffusion-tensor-based imaging method allowing reconstruction of nervous fibers. However, the swine model is not ideal due to major differences with human, more particularly the fact that the human pelvis contains a lot of fat unlike the swine pelvis, which is an interesting feature as there is a good contrast between fat and tissue in MRI. Therefore, it is important to perform new investigations in healthy volunteers to refine and assess the MRI acquisitions. Those investigations will be performed with a 3Tesla (3T) system from the same manufacturer, providing the same sequences but a higher field strength which should offer higher signal. There will be no injection of contrast agent. The protocol will use standard sequences from the manufacturer with parameters adjusted for the purposes of the study. The image quality will be scored on a 5-point Likert scale (0 = no possible delineation to 4=nerves are entirely visible).

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
All
接受健康志愿者

入选标准

  • Volunteers, male or female, from 18 years old
  • Volunteers able to understand the study and to provide informed consent
  • Volunteers affiliated to the French social security system

排除标准

  • Volunteer with contraindications to MRI (implanted device like pace-maker or neurostimulator, ferromagnetic materials, claustrophobia or obesity)
  • Volunteer that already underwent pelvic surgery
  • Volunteer pregnant or breastfeeding
  • Volunteer unable to provide informed consent
  • Volunteer refusing to be informed of any anomaly during an exam
  • Volunteer that already received more than 4500€ of allowance for biomedical testing
  • Volunteer in exclusion period (determined by a previous study or in progress)
  • Volunteer having forfeited their freedom of an administrative or legal obligation
  • Volunteer under guardianship
  • Volunteer carrying a multiresistant bacteria

研究组 & 干预措施

MRI acquisition - no contrast agent

Experimental

Volunteers will have an MRI with a 3T clinical system. Installation will be performed according to standard protocols. Different neurography and tractography sequences will be acquired in order to get different contrasts.

干预措施: MRI acquisition - no contrast agent (Procedure)

结局指标

主要结局

Assessment of image quality to delineate and identify nerves

时间窗: At the time of exam

The assessment of image quality to delineate and identify nerves will be scored on a five-point Likert scale by the operator, and independently reviewed by a radiologist.

次要结局

  • Acquisition time for neurography and tractography methods(At the time of exam)
  • Image quality at 1.5T and 3T by comparison of signal-to-noise ratios(At the time of exam)
  • Comparative evaluation score for neurography and tractography methods(Through study completion, an average of 1 year)

研究者

发起方
IHU Strasbourg
申办方类型
Other
责任方
Sponsor

研究点 (2)

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