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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03320343

Acronym

NERVWATCH

Enrollment

Registered

2017-10-25

Start date

2019-02-22

Completion date

2019-07-19

Last updated

2026-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic MRI

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

Interventions

OTHERMRI

3D morphological MRI and diffusion tensor imaging

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 17, 2026