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Completed

NCT Number: NCT03320343

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

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

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Key information

Conditions

Pelvic MRI

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Other

3D morphological MRI and diffusion tensor imaging

Primary outcomes

  1. Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic splanchnic nerves in the lower hypogastric plexus

    Time frame: Day 0

    Lin's concordance correlation coefficient and Bland-Altman Plot

  2. Agreement between DTI imaging measures versus 3D morphological MRI measures for point of penetration of the pelvic hypogastric nerves in the lower hypogastric plexus

    Time frame: Day 0

    Lin's concordance correlation coefficient and Bland-Altman Plot

  3. Agreement between DTI imaging measures versus 3D morphological MRI measures for origin of the cavernous nerves

    Time frame: Day 0

    Lin's concordance correlation coefficient and Bland-Altman Plot

Secondary outcomes

  1. Acquisition time

    Time frame: Day 0

    min

  2. Time necessary for sequence reconstruction

    Time frame: Day 0

    min

  3. Inter-operator agreement

    Time frame: Day 0

    Kappa coefficient of measurements between two operators

  4. Intra-operator agreement

    Time frame: Month 6

    Kappa coefficient of measurements from same operator 6 months apart

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: NERVWATCH

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Oct 25, 2017
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.