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

Healthy Volunteers Clinical Trial

— Neuro-Tracto  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02582346
• Other study ID #: 15-004
• Status: Completed
• Phase: N/A
• First received: October 16, 2015
• Last updated: March 12, 2018
• Start date: November 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2018
• Source: IHU Strasbourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
France	Institut de Physique Biologique - Laboratoire iCube UMR 7357 UdS/CNRS	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

References & Publications (12)

Baader B, Herrmann M. Topography of the pelvic autonomic nervous system and its potential impact on surgical intervention in the pelvis. Clin Anat. 2003 Mar;16(2):119-30. — View Citation

Bertrand MM, Macri F, Mazars R, Droupy S, Beregi JP, Prudhomme M. MRI-based 3D pelvic autonomous innervation: a first step towards image-guided pelvic surgery. Eur Radiol. 2014 Aug;24(8):1989-97. doi: 10.1007/s00330-014-3211-0. Epub 2014 May 17. — View Citation

Chang KJ, Kamel IR, Macura KJ, Bluemke DA. 3.0-T MR imaging of the abdomen: comparison with 1.5 T. Radiographics. 2008 Nov-Dec;28(7):1983-98. doi: 10.1148/rg.287075154. Review. — View Citation

Filler AG, Howe FA, Hayes CE, Kliot M, Winn HR, Bell BA, Griffiths JR, Tsuruda JS. Magnetic resonance neurography. Lancet. 1993 Mar 13;341(8846):659-61. — View Citation

Lange MM, Marijnen CA, Maas CP, Putter H, Rutten HJ, Stiggelbout AM, Meershoek-Klein Kranenbarg E, van de Velde CJ; Cooperative clinical investigators of the Dutch. Risk factors for sexual dysfunction after rectal cancer treatment. Eur J Cancer. 2009 Jun;45(9):1578-88. doi: 10.1016/j.ejca.2008.12.014. Epub 2009 Jan 13. — View Citation

Lim KS, Tan CH. Diffusion-weighted MRI of adult male pelvic cancers. Clin Radiol. 2012 Sep;67(9):899-908. doi: 10.1016/j.crad.2012.01.016. Epub 2012 Apr 11. Review. — View Citation

Porter GA, Soskolne CL, Yakimets WW, Newman SC. Surgeon-related factors and outcome in rectal cancer. Ann Surg. 1998 Feb;227(2):157-67. — View Citation

Shihab OC, Heald RJ, Rullier E, Brown G, Holm T, Quirke P, Moran BJ. Defining the surgical planes on MRI improves surgery for cancer of the low rectum. Lancet Oncol. 2009 Dec;10(12):1207-11. doi: 10.1016/S1470-2045(09)70084-1. — View Citation

Soler L, Nicolau S, Pessaux P, Mutter D, Marescaux J. Real-time 3D image reconstruction guidance in liver resection surgery. Hepatobiliary Surg Nutr. 2014 Apr;3(2):73-81. doi: 10.3978/j.issn.2304-3881.2014.02.03. — View Citation

Takahara T, Hendrikse J, Yamashita T, Mali WP, Kwee TC, Imai Y, Luijten PR. Diffusion-weighted MR neurography of the brachial plexus: feasibility study. Radiology. 2008 Nov;249(2):653-60. doi: 10.1148/radiol.2492071826. Epub 2008 Sep 16. — View Citation

van der Jagt PK, Dik P, Froeling M, Kwee TC, Nievelstein RA, ten Haken B, Leemans A. Architectural configuration and microstructural properties of the sacral plexus: a diffusion tensor MRI and fiber tractography study. Neuroimage. 2012 Sep;62(3):1792-9. doi: 10.1016/j.neuroimage.2012.06.001. Epub 2012 Jun 13. — View Citation

Wijsmuller AR, Giraudeau C, Leroy J, Kleinrensink GJ, Rociu E, Romagnolo LG, Melani AGF, Agnus V, Diana M, Soler L, Dallemagne B, Marescaux J, Mutter D. A step towards stereotactic navigation during pelvic surgery: 3D nerve topography. Surg Endosc. 2018 F — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At the time of exam
Secondary	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.	At the time of exam
Secondary	Comparative evaluation score for neurography and tractography methods	Neurography and tractography methods will be scored on a five-point Lickert scale.	Through study completion, an average of 1 year
Secondary	Acquisition time for neurography and tractography methods	Required acquisition time for neurography and tractography methods will be compared if evaluation scores are equivalent.	At the time of exam