An interventional study of MRI acquisition - no contrast agent in Healthy Volunteers, sponsored by IHU Strasbourg. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-14.
Sponsored by IHU Strasbourg · Not applicable, Interventional, and Prevention
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.
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).
IHU Strasbourg is the lead sponsor of 43 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
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.
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.
Assessment of image quality to delineate and identify nerves
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.
Time frame: At the time of exam
Image quality at 1.5T and 3T by comparison of signal-to-noise ratios
Assessment of signal-to-noise ratios to compare 1.5T and 3T fields.
Time frame: At the time of exam
Comparative evaluation score for neurography and tractography methods
Neurography and tractography methods will be scored on a five-point Lickert scale.
Time frame: Through study completion, an average of 1 year
Acquisition time for neurography and tractography methods
Required acquisition time for neurography and tractography methods will be compared if evaluation scores are equivalent.
Time frame: At the time of exam
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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