Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions

Endometriosis Clinical Trial

— ENDOFUSION  

Official title:

Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions ENDOFUSION

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04554602
• Other study ID #: APHP191069
• Secondary ID: 2019-A02828-49
• Status: Active, not recruiting
• Start date: March 1, 2021
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 24
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endometriosis

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
France	AP-HP, Bicêtre Hospital	Le Kremlin Bicêtre

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the diagnostic performance of fusion ultrasound compared to transvaginal gynaecological ultrasound and MRI for the diagnosis of endometriosis lesions.	3 years and 3 months
Secondary	Evaluate the reproducibility of the conclusions of the fusion ultrasound between 2 operators.	Evaluation of the reproducibility by an intra-class correlation test for the conclusions of fusion ultrasound between two operators.	3 years and 3 months
Secondary	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.	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	3 years and 3 months
Secondary	Compare the duration of a standard ultrasound scan to an ultrasound scan with fusion	Comparison of the average examination time by a Student T-test between standard and fusion ultrasound.	3 years and 3 months
Secondary	Evaluation of the cost of imaging for 3 years between an annual fusion ultrasound surveillance in replacement of a annual MRI surveillance	Comparison of imaging costs will be carried out over 3 years between a conventional procedure with annual MRI and the procedure being evaluated	3 years and 3 months