Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI

NCT06577831 | Completed

• 1 other identifier: RCAPHM20_0016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Deformity

Outcome Measures

Primary Outcomes (1)

• Develop new three-dimensional analysis tools combining high spatial resolution static MRI with ultra-fast dynamic MRI.

  a metric for displacement of the anchor points of the targeted pelvic organs will be evaluated

  0 month

Study Arms (2)

patient

EXPERIMENTAL

Patients requiring dynamic MRI for the diagnosis of pelvic static disorders

Diagnostic Test: dynamic MRI

control

ACTIVE COMPARATOR

Healthy volunteers for a dynamic MRI

Diagnostic Test: dynamic MRI

Interventions

dynamic MRI DIAGNOSTIC_TEST

* MRI sequences will be performed for patients and healthy volunteers i * Vaginal and rectal tagging will be performed using a water-based ultrasound gel. * The gel will be inserted by an authorized person (nurse or doctor) using a syringe with a conical tip and, optionally, a probe. * MRI sequences. * Data analysis and interpretation.

control; patient

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women, +/- of childbearing age, with or without effective contraception.
• Informed consent signed prior to any procedure described in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille _ Hopital de la Timone

Marseille, France, 13005, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 29, 2024
• Study Start: February 25, 2022
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)