ENDO-MRI: ENDOMETRIOSIS - MRI

Sponsor
University Hospital, Lille (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05779462
Collaborator
(none)
52
17.1

Study Details

Study Description

Brief Summary

Endometriosis is a frequent pathology with an estimated prevalence of 10% of women of childbearing age. There is no exact correspondence between the symptoms described by the patients and the severity of the lesions, which makes clinical diagnosis difficult. It therefore seems important to improve the complementary examinations available to make the diagnosis more precise and to better study the effectiveness of the treatments implemented. The clinical examination and per-surgical findings of patients with deep pelvic endometriosis show a clear decrease in the mobility of the pelvic organs in relation to each other, but few studies have looked at this mobility, which could however have an implication in explaining the pathophysiology of the disease and the symptomatology of the patients, as well as in the detection of lesions preoperatively. The persistence of hypo-mobility could also help to understand treatment failures.

Condition or Disease Intervention/Treatment Phase
  • Other: Dynamic MRI Sequence

Study Design

Study Type:
Observational
Anticipated Enrollment :
52 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Study of Pelvic Organ Mobility by Dynamic MRI in Pelvic Endometriosis
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
patients with pelvic endometriosis

Patients referred for suspected pelvic endometriosis, with pelvic endometriosis on initial MRI

Other: Dynamic MRI Sequence
Addition of a Dynamic MRI Sequence during the MRI examination performed in routine care

patients without pelvic endometriosis

Patients referred for suspected pelvic endometriosis but without endometriosis found on diagnostic MRI.

Other: Dynamic MRI Sequence
Addition of a Dynamic MRI Sequence during the MRI examination performed in routine care

Outcome Measures

Primary Outcome Measures

  1. the mean vertical displacement (in millimeters) measured on the anterior wall of the vagina between rest and maximum pushing force during dynamic MRI [Baseline]

Secondary Outcome Measures

  1. the mean vertical displacement (in millimetres) measured on the cervix between rest and maximum thrust effort during dynamic MRI. [Baseline]

  2. the mean vertical displacement (in millimetres) measured on the posterior wall of the vagina between rest and maximum pushing force during dynamic MRI. [Baseline]

  3. the measurement of variation in mean vertical displacement (in millimetres) on the wall of each pelvic organ at the push effort between the initial dynamic MRI of patients with [Baseline]

  4. the statistical association between the symptoms of patients with endometriosis and the mean vertical displacement (in millimetres) on the wall of each pelvic organ at the push effort during dynamic MRI. [Baseline]

    Initial symptoms are associated with initial dynamic MRI data and post therapeutic symptoms are associated with post-therapeutic dynamic MRI data. The symptoms of interest are dysmenorrhea, non-cyclic pelvic pain, dysuria, dychesia, transit disorders (diarrhea/constipation), and dyspareunia.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patient referred for suspected pelvic endometriosis requiring pelvic MRI

  • Female, nulliparous,

  • patient with signed written consent, patient with health insurance,

  • patient willing to comply with all study procedures and duration

Exclusion Criteria:
  • BMI > 35,

  • history of hereditary collagen and elastic tissue disease,

  • history of pelviperitonitis,

  • history of major pelvic surgery,

  • inability to receive informed information,

  • inability to participate in the entire study,

  • lack of social security coverage,

  • refusal to sign consent

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Hospital, Lille

Investigators

  • Principal Investigator: Chrystele RUBOD, MD,PhD, University Hospital, Lille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT05779462
Other Study ID Numbers:
  • 2022_0032
  • 2022-A02135-38
First Posted:
Mar 22, 2023
Last Update Posted:
Mar 22, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Lille
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2023