Clinical trial NCT02582346: Assessment of Magnetic Resonance Imaging Neurography and Tractography for Preoperative Mapping of Pelvic Nerves
Official title: Assessment of Magnetic Resonance Imaging Neurography and Tractography for Preoperative Mapping of Pelvic Nerves
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: MRI
Neurography
Tractography
Pelvic nerves
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2015-10-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Assessment of image quality to delineate and identify nerves
timeFrame: At the time of exam
Secondary outcomes:
measure: Image quality at 1.5T and 3T by comparison of signal-to-noise ratios
timeFrame: At the time of exam
measure: Comparative evaluation score for neurography and tractography methods
timeFrame: Through study completion, an average of 1 year
measure: Acquisition time for neurography and tractography methods
timeFrame: At the time of exam
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Institut de Physique Biologique - Laboratoire iCube UMR 7357 UdS/CNRS
Study officials:
affiliation: Institut de Physique Biologique - Laboratoire iCube UMR 7357 UdS/CNRS Strasbourg
name: Daniel Grucker, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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