Diffusion Endometriosis MRI to Detect and Quantify Symptomatic Neurological Impairment in Pelvic … (NCT06908655) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Diffusion Endometriosis MRI to Detect and Quantify Symptomatic Neurological Impairment in Pelvic Endometriosis
France110 participantsStarted 2025-04-01
Plain-language 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.
Who can participate
Age range
18 Years – 90 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
At least one measurable parameter (yes/no) on tractography in patients with or without endometriosis.
Timeframe: 3 months
2
Proportion of patients with at least one relevant parameter evaluated by MRI-based tractography, in patients with or without endometriosis