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

NCT06908655 | Not Yet Recruiting

• 3 other identifiers: APHP2414812024-A00538-3924.05788.000362
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

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

Keywords

endometriosis; tractography; pelvic nervous tract

Outcome Measures

Primary Outcomes (2)

• At least one measurable parameter (yes/no) on tractography in patients with or without endometriosis.

  Evaluate the ability of the diffusion tensor sequence to visualize normal or pathological pelvic nerve plexuses (hypogastric and sciatic) in pelvic endometriosis. These parameters will be measured on MRI tractography images.

  3 months

• Proportion of patients with at least one relevant parameter evaluated by MRI-based tractography, in patients with or without endometriosis

  Number of patients (with or without endometriosis) in whom at least one parameter could be evaluated, divided by the total number of patients (with or without endometriosis) who attended an MRI-based tractography. Parameters expected to be evaluable with MRI-based tractography: * total volume * lengths * number of branches * tortuosity MRI will be exploited by independant readers, blinded from patients'clinical characteristics and diagnosis

  Between 7 and 60 days after inclusion

Secondary Outcomes (13)

• Proportion of patients with an individual relevant parameter evaluated by MRI-based tractography, in patients with or without endometriosis

  Between 7 and 60 days after inclusion

• Total volume evaluated by MRI-based tractography

  Between 7 and 60 days after inclusion

• Length of branches evaluated by MRI-based tractography.

  Between 7 and 60 days after inclusion

• Number of branches evaluated by MRI-based tractography.

  Between 7 and 60 days after inclusion

• Tortuosity evaluated by MRI-based tractography.

  Between 7 and 60 days after inclusion

Study Arms (1)

Patients with symptoms compatible with possible endometriosis

EXPERIMENTAL

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.

Other: MRI

Interventions

MRI 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.

Patients with symptoms compatible with possible endometriosis

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Imagine Institute: collaborator
• Sauver la vie Fundation: collaborator

Study Sites (3)

C01 - Cochin Port Royal

Paris, 75014, France

Location

C02-HEGP gynecology

Paris, 75015, France

Location

C03- HEGP radiology

Paris, 75015, France

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Louis Marcellin

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cléo Bourgeois

CONTACT

0156095638; cleo.bourgeois@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, non-randomized, multicenter, diagnostic study.

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: April 3, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. The founder could be involved in the decision. Teams wishing obtain IPD must meet the sponsor and IP team to present scientifics (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractualization. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (3)