Clinical trial NCT06908655: Diffusion Endometriosis MRI to Detect and Quantify Symptomatic Neurological Impairment in Pelvic Endometriosis
Official title: Diffusion Endometriosis MRI to Detect and Quantify Symptomatic Neurological Impairment in Pelvic Endometriosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometriosis
Keywords: endometriosis
tractography
pelvic nervous tract
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Imagine Institute
name: Sauver la vie Fundation
First posted: 2025-04-03
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, non-randomized, multicenter, diagnostic study.
Primary purpose: DIAGNOSTIC

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.


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 outcomes:
measure: At least one measurable parameter (yes/no) on tractography in patients with or without endometriosis.
timeFrame: 3 months
measure: Proportion of patients with at least one relevant parameter evaluated by MRI-based tractography, in patients with or without endometriosis
timeFrame: Between 7 and 60 days after inclusion
Secondary outcomes:
measure: Proportion of patients with an individual relevant parameter evaluated by MRI-based tractography, in patients with or without endometriosis
timeFrame: Between 7 and 60 days after inclusion
measure: Total volume evaluated by MRI-based tractography
timeFrame: Between 7 and 60 days after inclusion
measure: Length of branches evaluated by MRI-based tractography.
timeFrame: Between 7 and 60 days after inclusion
measure: Number of branches evaluated by MRI-based tractography.
timeFrame: Between 7 and 60 days after inclusion
measure: Tortuosity evaluated by MRI-based tractography.
timeFrame: Between 7 and 60 days after inclusion
measure: Proportion of patients with nerve lesions, in patients with endometriosis
timeFrame: Baseline
measure: Inter-reader reproductibilty of nerve lesions, in patients with endometriosis
timeFrame: Baseline
measure: Fractional Anisotropy, in patients with vs without endometriosis
timeFrame: Between 7 and 60 days after inclusion
measure: Scores at EHP5 Quality of Life questionnaires, in patients with endometriosis
timeFrame: Baseline
measure: Scores at EHP30 Quality of Life questionnaires, in patients with endometriosis
timeFrame: Baseline
measure: DN4-based and visual analog scale for pain assessment, in patients with endometriosis
timeFrame: Baseline
measure: VAS for pain assessement at the end of MRI-based diffusion tensor sequence, in patients with vs without endometriosis
timeFrame: Between 7 and 60 days after inclusion
measure: Total examination duration and MRI-based sequence acquisition duration, in patients with vs without endometriosis
timeFrame: Between 7 and 60 days after inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: C01 - Cochin Port Royal
city: Paris
country: France
facility: C02-HEGP gynecology
city: Paris
country: France
facility: C03- HEGP radiology
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Louis Marcellin
role: PRINCIPAL_INVESTIGATOR
References: