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

NCT ID: NCT06908655

Last Updated: 2025-04-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-04-30

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.

Conditions

Endometriosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with symptoms compatible with possible endometriosis

Patients will have an initial gynecological surgery consultation to determine the indication for MRI to diagnose and/or assess pelvic endometriosis. MRI will be performed at the HEGP, comprising a T2-weighted isotropic thin-section (3D) cube sequence (1 mm3), and a T1-weighted isotropic 3D DIXON sequence (1 mm3), for a total duration of 20 minutes (including set-up). Patients will also have a pelvic ultrasound if they have not already had one at a center specializing in endometriosis.

They will have a further consultation after the MRI, so that the gynecological surgeon can discuss therapeutic management. All these procedures are performed as part of routine management.

Group Type: EXPERIMENTAL

MRI

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Imagine Institute

OTHER

Sponsor Role: collaborator

Sauver la vie Fundation

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Louis Marcellin

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

C01 - Cochin Port Royal

Paris, , France

C02-HEGP gynecology

Paris, , France

C03- HEGP radiology

Paris, , France

Countries

France

Central Contacts

Cléo Bourgeois

Role: CONTACT

cleo.bourgeois@aphp.fr

0156095638 ext. +33

Facility Contacts

Louis Marcellin

Role: primary

louis.marcellin@aphp.fr

0158413661 ext. +33

Anne-Sophie Bats

Role: primary

anne-sophie.bats@aphp.fr

0156093586 ext. +33

Laure Fournier

Role: primary

laure.fournier@aphp.fr

0156093851

Other Identifiers

2024-A00538-39

Identifier Type: OTHER

Identifier Source: secondary_id

24.05788.000362

Identifier Type: OTHER

Identifier Source: secondary_id

APHP241481

Identifier Type: -

Identifier Source: org_study_id