SUPerficial ENDometriosis In Magnetic Resonance Imaging

Endometriosis Clinical Trial

— SUPENDIM  

Official title:

Prospective, Multicenter Study Evaluating the Diagnostic Performance of the 3DT1 Sequence in Magnetic Resonance Imaging for Superficial Endometriosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06195280
• Other study ID #: 2023-A01336-39
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: March 2026

Study information

• Verified date: April 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Anne Elodie MILLISCHER-BELLAICHE, MD
• Phone: 6 16 23 93 81
• Email: aemillischer[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 112
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Intervention

Radiation:
• 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.

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

Locations

Country	Name	City	State
France	Clinique Blomet	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between the diagnosis of superficial endometriosis by the 3DT1 sequence in Magnetic Resonance Imaging and the histology obtained by laparoscopy	The diagnostic validity of Magnetic resonance imaging compared to laparoscopy will be determined by correlation between the locations of the sites screened on Magnetic resonance imaging (Douglas cul de sac, vesicouterine cul de sac, right ovarian fossa, left ovarian fossa, right broad ligament, left broad ligament) and histologically confirmed endometriotic implants at these sites.	between 30 and 150 days