Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions

Active, not recruiting

• Conditions: Endometriosis
• Interventions: Diagnostic Test: Fusion ultrasound

• Registration Number: NCT04554602
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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).

Study Timeline

• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-18
• Study Start: 2021-03-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-25
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 24

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with endometriosis or suspicion of endometriosis	Fusion ultrasound	* 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
Patient with other gynaecological pathology	Fusion ultrasound	* 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

Primary Outcome Measures

Name	Time	Method
Sensitivity, specificity, positive predictive value (VPP) and negative predictive value (VPN) of fusion ultrasound compared to transvaginal ultrasound and MRI for the diagnosis of endometriosis lesions	3 years and 3 months	To evaluate the diagnostic performance of fusion ultrasound compared to transvaginal gynaecological ultrasound and MRI for the diagnosis of endometriosis lesions.

Secondary Outcome Measures

Name	Time	Method
Compare the duration of a standard ultrasound scan to an ultrasound scan with fusion	3 years and 3 months	Comparison of the average examination time by a Student T-test between standard and fusion ultrasound.
Evaluate the reproducibility of the conclusions of the fusion ultrasound between 2 operators.	3 years and 3 months	Evaluation of the reproducibility by an intra-class correlation test for the conclusions of fusion ultrasound between two operators.
Evaluation of the cost of imaging for 3 years between an annual fusion ultrasound surveillance in replacement of a annual MRI surveillance	3 years and 3 months	Comparison of imaging costs will be carried out over 3 years between a conventional procedure with annual MRI and the procedure being evaluated
To evaluate the contribution of fusion ultrasound in the follow-up of patients suffering from endometriosis, in particular with an ultrasound follow-up in comparison with an initial reference MRI in the case of medical or surgical management.	3 years and 3 months	Correlation between the evolution of clinical and quality of life symptoms (EHP30 form and Short Form 36) and the evolution of lesion size between initial MRI and follow-up ultrasounds at 6 months and one year

Trial Locations

Locations (1)

AP-HP, Bicêtre Hospital; 🇫🇷 Le Kremlin Bicêtre, France