NCT02582346

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: IHU Strasbourg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
PROCEDURE	MRI acquisition - no contrast agent	No surgery. 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.

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2015-10-21
• Last updated: 2018-03-14

Locations

1 site across 1 country: France