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Completed

NCT Number: NCT02582346

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

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Physique Biologique - Laboratoire iCube UMR 7357 UdS/CNRS

Strasbourg, 67000, France

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI acquisition - no contrast agent

Procedure

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.

Primary outcomes

  1. Assessment of image quality to delineate and identify nerves

    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.

Secondary outcomes

  1. Image quality at 1.5T and 3T by comparison of signal-to-noise ratios

    Time frame: At the time of exam

    Assessment of signal-to-noise ratios to compare 1.5T and 3T fields.

  2. Comparative evaluation score for neurography and tractography methods

    Time frame: Through study completion, an average of 1 year

    Neurography and tractography methods will be scored on a five-point Lickert scale.

  3. Acquisition time for neurography and tractography methods

    Time frame: At the time of exam

    Required acquisition time for neurography and tractography methods will be compared if evaluation scores are equivalent.

Sponsors and collaborators

Lead sponsor

IHU Strasbourg

Other

Registry information

Acronym: Neuro-Tracto

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 21, 2015
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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