Clinical trial NCT06195280: SUPerficial ENDometriosis In Magnetic Resonance Imaging
Official title: Prospective, Multicenter Study Evaluating the Diagnostic Performance of the 3DT1 Sequence in Magnetic Resonance Imaging for Superficial Endometriosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Endometriosis
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
Collaborators: name: Euraxi Pharma
First posted: 2024-01-08
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicenter, non-randomized study
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the correlation between the diagnosis of Superficial endometriosis by the 3DT1 sequence on Magnetic resonance imaging and the histology obtained by laparoscopy.

Detailed description: This is a prospective, multicenter, non-randomized study evaluating the diagnostic performance of Magnetic Resonance Imaging in superficial endometriosis.

The duration of the patient's participation in the study is a maximum of 15 months depending on the length of the screening period and the time between Magnetic Resonance Imaging and laparoscopy.

After selection, the investigator will check the patient's eligibility and offer her the study. If she accepts and signs the informed consent form, the patient will have an exploratory pelvic Magnetic Resonance Imaging lasting approximately 15 to 20 minutes, without systematic injection of contrast product.

After Magnetic Resonance Imaging, the patient will benefit from a laparoscopy under general anesthesia lasting an average of one hour.

Eligibility criteria: Inclusion Criteria :

* Age ≥ 18 years;
* Non-menopausal patient;
* Patient scheduled for exploratory laparoscopy;
* Patient requiring a preoperative pelvic MRI
* Patient having been informed and having signed an informed consent form.

Exclusion Criteria :

* Classic contraindications to magnetic resonance imaging;
* Contraindications to anesthesia for exploratory laparoscopy;
* Contraindication to surgery following the findings of magnetic resonance imaging results;
* Patient with endometrioma \> 4 cm;
* Patient with known deep endometriosis;
* Patient uncooperative with protocol requirements or unable to attend the center for scheduled visits;
* Pregnant woman or woman of childbearing age, without effective contraception or breastfeeding;
* Patient participating in another clinical trial, or during a period of exclusion from another clinical trial;
* Patient under guardianship, under curatorship or subject to legal protection, persons deprived of liberty by a judicial or administrative decision, persons subject to psychiatric care and admitted to a health or social establishment;
* Patient not beneficiary of a social security system
* Patient under State Medical Aid.

Primary outcomes:
measure: Correlation between the diagnosis of superficial endometriosis by the 3DT1 sequence in Magnetic Resonance Imaging and the histology obtained by laparoscopy
timeFrame: between 30 and 150 days
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Blomet
Study officials:
References: