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

Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions ENDOFUSION

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

Study Overview

• Status: Active, not recruiting
• Conditions: Endometriosis
• Intervention / Treatment: Diagnostic test: Fusion ultrasound

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 Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

• Study Contact: Name: Perrine CAPMAS, DR; Phone Number: 0033145217590; Email: perrine.capmas@aphp.fr

Study Locations

• France
  • Le Kremlin Bicêtre, France, 94275
    • AP-HP, Bicêtre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Any major patient with an indication for pelvic MRI and pelvic ultrasound outside a proven cancer indication (suspicion of endometriosis or other pathology for the control population).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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.
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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Perrine CAPMAS, DR, APHP

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 14, 2020
• First Submitted That Met QC Criteria: September 14, 2020
• First Posted (Actual): September 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 25, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: APHP191069; 2019-A02828-49 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No