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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
Phase
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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