NCT06908655Not yet recruiting
Diffusion Endometriosis MRI to Detect and Quantify Symptomatic Neurological Impairment in Pelvic Endometriosis
Source: ClinicalTrials.gov · Last updated 3 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 13 Mar 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Endometriosis
- NCT number
- NCT06908655
What you commit to
- Study type: Interventional
- Planned participants: 110
- From 1 Apr 2025 to the primary completion date, 30 Apr 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous pelvic surgery;
- Patient having participated in a therapeutic clinical trial involving a new molecule within 30 days prior to inclusion;
- Patients receiving State Medical Aid.
Other illness
- Contraindication to MRI: ocular metallic foreign body, pacemaker, mechanical heart valve, old vascular clips on cerebral aneurysm;
- 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;
Other
- Pregnant or breast-feeding women
- Claustrophobic patients
- Contraindication to glucagen injection (anti-peristaltic);
- Vulnerable patients (legal protection, guardianship, curatorship);
Who the study is looking for
- 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
Age in the registry: 18 years to 90 years · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| C02-HEGP gynecology Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| C01 - Cochin Port Royal Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| C03- HEGP radiology Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.