NCT02582346

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy-volunteers

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
11 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 14, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

October 16, 2015

Last Update Submit

March 12, 2018

Conditions

Healthy Volunteers

Keywords

MRINeurographyTractographyPelvic nerves

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

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

    At the time of exam

  • Comparative evaluation score for neurography and tractography methods

    Through study completion, an average of 1 year

  • Acquisition time for neurography and tractography methods

    At the time of exam

Study Arms (1)

MRI acquisition - no contrast agent

EXPERIMENTAL

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

Interventions

MRI acquisition - no contrast agentPROCEDURE

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.

MRI acquisition - no contrast agent

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 having forfeited their freedom of an administrative or legal obligation
  • Volunteer under guardianship
  • Volunteer carrying a multiresistant bacteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Strasbourg, 67000, France

Location

Related Publications (12)

  • Porter GA, Soskolne CL, Yakimets WW, Newman SC. Surgeon-related factors and outcome in rectal cancer. Ann Surg. 1998 Feb;227(2):157-67. doi: 10.1097/00000658-199802000-00001.

    PMID: 9488510BACKGROUND

  • 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. doi: 10.1002/ca.10105.

    PMID: 12589666BACKGROUND

  • 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.

    PMID: 19147343BACKGROUND

  • 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.

    PMID: 22498730BACKGROUND

  • 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.

    PMID: 19959077BACKGROUND

  • 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. doi: 10.1016/0140-6736(93)90422-d.

    PMID: 8095572BACKGROUND

  • 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.

    PMID: 18796657BACKGROUND

  • 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.

    PMID: 22705377BACKGROUND

  • 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.

    PMID: 24838739BACKGROUND

  • 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.

    PMID: 24812598BACKGROUND

  • 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.

    PMID: 19001653BACKGROUND

  • 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 Aug;32(8):3582-3591. doi: 10.1007/s00464-018-6086-3. Epub 2018 Feb 12.

    PMID: 29435745RESULT

Study Officials

  • Daniel Grucker, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 21, 2015

Study Start

November 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 14, 2018

Record last verified: 2018-03

Locations

FR(1)