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

Recruiting

• Conditions: Pelvic MRI
• Interventions: Other: MRI

• Registration Number: NCT03320343
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-25
• Study Start: 2019-02-22
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-28
• Primary Completion: 2023-01
• Study Completion: 2023-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients recruited for pelvic imaging examination	MRI	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France