Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions (ENDOFUSION)

Assistance Publique - Hôpitaux de Paris

Status: Active, not recruiting

Conditions: Endometriosis

Treatments: Diagnostic Test: Fusion ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT04554602

APHP191069

2019-A02828-49 (Other Identifier)

Details and patient eligibility

About

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

Full 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).

Enrollment: 24 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

24 participants in 2 patient groups

Patient with endometriosis or suspicion of endometriosis

Description:

* 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

Treatment:

Diagnostic Test: Fusion ultrasound

Patient with other gynaecological pathology

Description:

* 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

Treatment:

Diagnostic Test: Fusion ultrasound