SUPerficial ENDometriosis In Magnetic Resonance Imaging (SUPENDIM)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Not yet enrolling

Conditions: Endometriosis

Treatments: Radiation: Magnetic resonance imaging, 3DT1 sequence; Procedure: Laparoscopy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06195280

2023-A01336-39

Details and patient eligibility

About

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.

Full 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.

Enrollment: 112 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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112 participants in 1 patient group

superficial endometriosis

Experimental group

Description:

Endometriosis is a chronic, estrogen-dependent inflammatory disease secondary to tissue growth outside the uterine cavity, affecting approximately 10% of women of childbearing age.

Treatment:

Procedure: Laparoscopy

Radiation: Magnetic resonance imaging, 3DT1 sequence