Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions

NCT04554602 | Active Not Recruiting

• 2 other identifiers: APHP1910692019-A02828-49
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Evaluate the reproducibility of the conclusions of the fusion ultrasound between 2 operators.

  3 years and 3 months

• 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

• Compare the duration of a standard ultrasound scan to an ultrasound scan with fusion

  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

  3 years and 3 months

Study Arms (2)

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

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

Interventions

Fusion ultrasound 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 endometriosis or suspicion of endometriosis; Patient with other gynaecological pathology

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

AP-HP, Bicêtre Hospital

Le Kremlin-Bicêtre, 94275, France

Location

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Perrine CAPMAS, DR

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 18, 2020
• Study Start: March 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 25, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)