Clinical trial NCT04554602: Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions
Official title: Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions ENDOFUSION
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Endometriosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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).

Eligibility criteria: 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)

Primary outcomes:
measure: 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
timeFrame: 3 years and 3 months
Secondary outcomes:
measure: Evaluate the reproducibility of the conclusions of the fusion ultrasound between 2 operators.
timeFrame: 3 years and 3 months
measure: 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.
timeFrame: 3 years and 3 months
measure: Compare the duration of a standard ultrasound scan to an ultrasound scan with fusion
timeFrame: 3 years and 3 months
measure: Evaluation of the cost of imaging for 3 years between an annual fusion ultrasound surveillance in replacement of a annual MRI surveillance
timeFrame: 3 years and 3 months
Other outcomes:
Locations:
city: Le Kremlin Bicêtre
country: France
facility: AP-HP, Bicêtre Hospital
Study officials:
affiliation: APHP
name: Perrine CAPMAS, DR
role: PRINCIPAL_INVESTIGATOR
References: