Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI (NCT06577831) | Clinical Trial Compass
CompletedNot Applicable
Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI
France50 participantsStarted 2022-02-25
Plain-language summary
Pelvic floor disorders affect a large population of women and are responsible for a significant impairment in their quality of life, but the pathophysiology of these disorders is still poorly understood.
The project proposes to define new ultra-fast 3D MRI sequences to capture the movements of the main pelvic organs. Visualization of 3D volumes is of great importance to clinicians, but data size hinders clinical use.
This study is the first to propose a dynamic 3D representation of pelvic organs, together with quantitative estimates of the deformations undergone.
The method is based on four steps: dynamic acquisition, organ segmentation, temporal reconstruction, quantification and visualization of deformations.
The D3-Pelvis project responds to the challenge of "technologies for health" with dynamic 3D MRI acquisition and 3D modeling, offering prospects for diagnostic aids and simulators.
Who can participate
Age range
18 Years
Sex
FEMALE
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:
* Adult women, +/- of childbearing age, with or without effective contraception.
* Informed consent signed prior to any procedure described in the study.
Exclusion Criteria:
* Contraindication to MRI,
* Impossibility of performing the examination during thrust,
* Minor patients
* Pregnant or breast-feeding women,
* Women of legal age under guardianship
* Persons staying in a health or social institution,
* People in emergency situations,
* Persons not covered by a social security scheme,
* Persons deprived of their liberty.
* Specifically, women with IUDs will be excluded if they cannot remove them before the examination.
* For healthy volunteers: history of colorectal 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
1
Develop new three-dimensional analysis tools combining high spatial resolution static MRI with ultra-fast dynamic MRI.