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ClinicalTrials.gov ID

NCT06908655

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

110Estimated

Last Update Posted

Apr 3, 2025Actual

Start Date

Apr 1, 2025Estimated

Primary Completion Date

Apr 30, 2027Estimated

Completion Date

Apr 30, 2027Estimated

Official Title

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

Brief 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.

• Endometriosis

• MRI

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Women aged ≥ 18 years
• Non-menopausal (menopause defined as absence of menstrual periods for 12 consecutive months)
• Referred to the department for clinical suspicion of endometriosis on questioning Or known endometriosis
• Requiring specialized MRI by a specialist in endometriosis and adenomyosis imaging for diagnosis or follow-up of endometriosis.
• Patient affiliated to social security
• Patient with signed informed consent
• Patient with a good understanding of the French language

Exclusion Criteria:

• Pregnant or breast-feeding women
• Contraindication to MRI: ocular metallic foreign body, pacemaker, mechanical heart valve, old vascular clips on cerebral aneurysm;
• Claustrophobic patients
• Contraindication to glucagen injection (anti-peristaltic);
• Previous pelvic surgery;
• Patient having participated in a therapeutic clinical trial involving a new molecule within 30 days prior to inclusion;
• suffering from a severe chronic disease (cancer, HIV, renal failure, ongoing liver or biliary disorders, chronic inflammatory digestive disease, arthritis or other chronic respiratory disorders) or gastrointestinal disorders deemed incompatible with the conduct of the study by the investigator;
• Vulnerable patients (legal protection, guardianship, curatorship);
• Patients receiving State Medical Aid.

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Assistance Publique - Hôpitaux de ParisOTHER

Collaborators

Imagine InstituteOTHER

Sauver la vie FundationUNKNOWN

anne-sophie.bats@aphp.fr0156093586 ext. +33

laure.fournier@aphp.fr0156093851