Diffusion Endometriosis MRI to Detect and Quantify Symptomatic Neurological Impairment in Pelvic Endometriosis

NCT06908655 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2025-04-03

No results posted yet for this study

Summary

This research focuses on evaluating the ability of diffusion tensor imaging (DTI) to detect nerve damage in pelvic endometriosis. The primary objective is to visualize pelvic nerve plexuses to better understand the mechanisms of endometriosis-related neuropathic pain. Secondary objectives include comparing nerve damage between women with and without endometriosis.

To answer this question, it is planned to include 110 women with symptoms compatible with endometriosis, in Paris hospitals (Hôpital Cochin and HEGP). This research is funded by Assistance Publique - Hôpitaux de Paris. The expected duration of the research is 2 years, with individual participation of 3 months.

The research process will be as follows:

* Visit 0 (V0): Initial consultation to assess your state of health, complete pain questionnaires (EHP5, EHP30, DN4, EVA), and obtain your informed consent. Prescription of MRI.
* Visit 1 (V1): MRI with diffusion tensor imaging (DTI) within 60 days of V0. The MRI examination will be 10 minutes longer than the usual MRI. An intramuscular injection of glucagon hydrochloride will be given as part of the treatment.
* Visit 2 (V2): Follow-up consultation at 3 months, where the results of the standard MRI sequences will be discussed.

Research constraints and modalities:

* The addition of the DTI sequence extends the routine MRI by 10 minutes.
* You must attend each scheduled appointment. If you are unable to attend, please inform your doctor.
* No additional medications, treatments or samples are required for this study. You will be expected to follow your usual endometriosis treatments, with no specific restrictions on the drugs used, but please report any use of alternative medicine to your doctor.

No additional hospitalization is planned.

Conditions

  • Endometriosis

Interventions

OTHER

MRI

The procedure to be investigated will be to perform a diffusion tensor sequence during the MRI indicated as part of the treatment. The diffusion tensor sequence takes 10 minutes to acquire, for a total examination time of 30 minutes instead of 20 minutes, including set-up.

Sponsors & Collaborators

  • Imagine Institute

    collaborator OTHER
  • Sauver la vie Fundation

    collaborator UNKNOWN
  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Louis Marcellin · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2027-04-30
Completion
2027-04-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06908655 on ClinicalTrials.gov