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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02828-49 | Other Identifier | IDRCB |
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The aim of the study is evaluate the fusion ultrasound performance compared to MRI and coelioscopy diagnosis when a surgical intervention is performed.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with endometriosis or suspicion of endometriosis |
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| Patient with other gynaecological pathology |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Perrine CAPMAS, DR | APHP | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, BicĂȘtre Hospital | Le Kremlin-BicĂȘtre | 94275 | France |
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| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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 |
| 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 |
| 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 |
| D000091662 | Genital Diseases |