Institut de Physique Biologique - Laboratoire iCube UMR 7357 UdS/CNRS
Strasbourg, 67000, France
NCT Number: NCT02582346
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Strasbourg, 67000, France
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: At the time of exam
Assessment of signal-to-noise ratios to compare 1.5T and 3T fields.
Time frame: Through study completion, an average of 1 year
Neurography and tractography methods will be scored on a five-point Lickert scale.
Time frame: At the time of exam
Required acquisition time for neurography and tractography methods will be compared if evaluation scores are equivalent.
IHU Strasbourg
Other
Acronym: Neuro-Tracto
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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