SUPerficial ENDometriosis In Magnetic Resonance Imaging

NCT ID: NCT06195280

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2026-03-31

Brief Summary

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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

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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.

Conditions

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Endometriosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, multicenter, non-randomized study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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superficial endometriosis

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

Group Type EXPERIMENTAL

Magnetic resonance imaging, 3DT1 sequence

Intervention Type RADIATION

The patient will have an exploration pelvic Magnetic Resonance Imaging lasting approximately 15 to 20 minutes, without systematic injection of contrast product.

Laparoscopy

Intervention Type PROCEDURE

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

Interventions

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Magnetic resonance imaging, 3DT1 sequence

The patient will have an exploration pelvic Magnetic Resonance Imaging lasting approximately 15 to 20 minutes, without systematic injection of contrast product.

Intervention Type RADIATION

Laparoscopy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Euraxi Pharma

INDUSTRY

Sponsor Role collaborator

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique Blomet

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2023-A01336-39

Identifier Type: -

Identifier Source: org_study_id

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