Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI

Not Applicable

Completed

• Conditions: Pelvic Deformity
• Interventions: Diagnostic Test: dynamic MRI

• Registration Number: NCT06577831
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-25
• Study First Submitted: 2024-08-27
• Study First Submitted QC: 2024-08-27
• Study First Posted: 2024-08-29
• Primary Completion: 2025-02-24
• Study Completion: 2025-02-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patient	dynamic MRI	Patients requiring dynamic MRI for the diagnosis of pelvic static disorders
control	dynamic MRI	Healthy volunteers for a dynamic MRI

Primary Outcome Measures

Name	Time	Method
Develop new three-dimensional analysis tools combining high spatial resolution static MRI with ultra-fast dynamic MRI.	0 month	a metric for displacement of the anchor points of the targeted pelvic organs will be evaluated

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille _ Hopital de la Timone; 🇫🇷 Marseille, France