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

NCT03320343 | Unknown

• 1 other identifier: NIMAO/2017-01/MB-01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pelvic MRI

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Acquisition time

  Day 0

• Time necessary for sequence reconstruction

  Day 0

• Inter-operator agreement

  Day 0

• Intra-operator agreement

  Month 6

Study Arms (1)

Patients recruited for pelvic imaging examination

Other: MRI

Interventions

MRI OTHER

3D morphological MRI and diffusion tensor imaging

Patients recruited for pelvic imaging examination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

RECRUITING

Central Study Contacts

Martin Bertrand, MD

CONTACT

+33 (0)6 43 50 35 22; martin.bertrand@chu-nimes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 25, 2017
• Study Start: February 22, 2019
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: September 28, 2022

Record last verified: 2022-09

Locations

FR (1)