Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions

NCT ID: NCT04554602

Last Updated: 2024-01-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 24 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2026-12-31

Brief Summary

The aim of the study is evaluate the fusion ultrasound performance compared to MRI and coelioscopy diagnosis when a surgical intervention is performed.

Detailed Description

The research is about diagnosis performance between fusion ultrasound and the gold standard (MRI coelioscopy ). Fusion ultrasound is a no-invasive scientific technical which allow with security to evaluate the progress of endometriosis lesions. During 39 months, 200 patients will be follow. In one arm, there is the control group with women without endometriosis. In the second arm, there is the patient with endometriosis. We will compare monitoring differences between gold standard and fusion ultrasound ( Cost assessment,exams duration, reproductibility, the link between symptoms and evolution of the lesion size).

Conditions

Endometriosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient with endometriosis or suspicion of endometriosis

• Information and collection of the non-objection before inclusion
• Interrogation, clinical examination, EHP30 and SF36 form at inclusion
• MRI, pelvic ultrasound (coupled with fusion ultrasound)
• Laparoscopy if indicated after MRI, ultrasound and fusion ultrasound
• Monitoring by form and fusion ultrasound at 6 months and then once a year for 3 years

Fusion ultrasound

Intervention Type: DIAGNOSTIC_TEST

Fusion ultrasound is a technique that allows a volume acquired in MRI to be coupled to an ultrasound scan with real-time image synchronisation.

Patient with other gynaecological pathology

• Information and collection of the non-opposition before inclusion
• Interrogation, clinical examination, EHP30 and SF36 form at inclusion
• MRI, pelvic ultrasound (coupled with fusion ultrasound)
• laparoscopy if indicated after MRI, ultrasound and fusion ultrasound

Fusion ultrasound

Intervention Type: DIAGNOSTIC_TEST

Fusion ultrasound is a technique that allows a volume acquired in MRI to be coupled to an ultrasound scan with real-time image synchronisation.

Interventions

Fusion ultrasound

Fusion ultrasound is a technique that allows a volume acquired in MRI to be coupled to an ultrasound scan with real-time image synchronisation.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients from 18 to 50 years old
• Patient informed and who gave her non-opposition to participate in the research
• Patient with an indication for pelvic MRI and pelvic ultrasound either for the exploration of endometriosis or pelvic pain, or for another gynaecological pathology (ovarian cyst, poly-myomatous uterus, uterine malformation) outside of a proven cancer indication.
• Patient affiliated to a social security or entitled to a social security allowance

Exclusion Criteria

• Patient with a proven cancerous pathology at the time of the prescription of the complementary examinations.
• Virgin patient
• Pregnant patient
• Patients under protective measures
• Contraindication to MRI (claustrophobia, intracorporeal metallic foreign body)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Perrine CAPMAS, DR

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, , France

Countries

France

Other Identifiers

2019-A02828-49

Identifier Type: OTHER

Identifier Source: secondary_id

APHP191069

Identifier Type: -

Identifier Source: org_study_id