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Clinical Trials/NCT06577831
NCT06577831
Completed
N/A

Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI

Assistance Publique Hopitaux De Marseille1 site in 1 country50 target enrollmentFebruary 25, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pelvic Deformity
Sponsor
Assistance Publique Hopitaux De Marseille
Enrollment
50
Locations
1
Primary Endpoint
Develop new three-dimensional analysis tools combining high spatial resolution static MRI with ultra-fast dynamic MRI.
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 25, 2022
End Date
February 24, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 0 month

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

Study Sites (1)

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