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Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI

Dynamic Monitoring and Characterization of Pelvic by 3D Ultrafast MRI

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06577831
Acronym
DYNPELVIS
Enrollment
50
Registered
2024-08-29
Start date
2022-02-25
Completion date
2025-02-24
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Deformity

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.

Interventions

DIAGNOSTIC_TESTdynamic MRI

* 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.

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026