CompletedNot Applicable

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

France20 participantsStarted 2019-02-22

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: Day 0

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

Timeframe: Day 0

Trial details

NCT IDNCT03320343

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-07-19

View on ClinicalTrials.gov More Pelvic MRI trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: 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

Timeframe: Day 0

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

Timeframe: Day 0