Pilot Study of Measurement Agreement Between Morphological and Diffusion Tensor Imaging MRI for Pelvic Nerve Cartography (NERVWATCH)

The investigators hypothesize that diffusion tensor imaging (DTI) will produce a similar map of autonomic pelvic innervation to that obtained using 3D morphological MRI sequences

Study Overview

• Status: Recruiting
• Conditions: Pelvic MRI
• Intervention / Treatment: Other: MRI

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

• Study Contact: Name: Martin Bertrand, MD; Phone Number: +33 (0)6 43 50 35 22; Email: martin.bertrand@chu-nimes.fr

Study Locations

• France
  • Nîmes, France, 30029
    • Recruiting
    • CHU Nîmes
    • Contact: Anissa Megzari; Phone Number: +33 (0)4.66.68.42.36
    • Sub-Investigator: Julien Frandon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to the Medical Imaging Department of the CHU Nîmes for an MRI examination of the pelvic region for any reason

Description

Inclusion Criteria:

• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan
• The patient it at least 18 years old
• The patient has been admitted for an MRI examination of the pelvic region, for any reason

Exclusion Criteria:

• The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
• The subject refuses to sign the consent
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship
• The patient is pregnant or breast feeding
• There is a contra-indication for MRI (pacemaker, claustrophobic patient)
• The patient has had previous pelvic surgery

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients recruited for pelvic imaging examination	Other: MRI; 3D morphological MRI and diffusion tensor imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic splanchnic nerves in the lower hypogastric plexus	Lin's concordance correlation coefficient and Bland-Altman Plot	Day 0
Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic hypogastric nerves in the lower hypogastric plexus	Lin's concordance correlation coefficient and Bland-Altman Plot	Day 0
Agreement between DTI imaging measures versus 3D morphological MRI measures for origin of the cavernous nerves	Lin's concordance correlation coefficient and Bland-Altman Plot	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acquisition time	min	Day 0
Time necessary for sequence reconstruction	min	Day 0
Inter-operator agreement	Kappa coefficient of measurements between two operators	Day 0
Intra-operator agreement	Kappa coefficient of measurements from same operator 6 months apart	Month 6

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 22, 2019
• Primary Completion (ANTICIPATED): January 1, 2023
• Study Completion (ANTICIPATED): January 1, 2023

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (ACTUAL): October 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: NIMAO/2017-01/MB-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No