Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI (DYNPELVIS)

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Completed

Conditions: Pelvic Deformity

Treatments: Diagnostic Test: dynamic MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT06577831

RCAPHM20_0016

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

patient

Experimental group

Description:

Patients requiring dynamic MRI for the diagnosis of pelvic static disorders

Treatment:

Diagnostic Test: dynamic MRI

control

Active Comparator group

Description:

Healthy volunteers for a dynamic MRI

Treatment:

Diagnostic Test: dynamic MRI