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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A02456-39 | Other Identifier | French ANSM |
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The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients with metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI-PDFF.
The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients metabolic-dysfunction associated liver diseases (MASLD), by comparing its measurements with current diagnostic modalities, such as MRI PDFF.
The primary objective is to compare ultrasound parameters measurements of ultrasound attenuation, backscattering coefficient and sound speed to the hepatic fat fraction as measured with MRI-PDFF.
The secondary objectives includes the comparison of measurements of quantitative ultrasound parameters between Hepatoscope and FibroScan, and to compare the measurement of liver stiffness between Hepatoscope and MRE.
Exploratory objectives have been determined to allow the comparison of said measured parameters to the outcome of histopathological analysis in a subset patient population who would benefit from a liver biopsy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main cohort | Experimental | Patients recruited in the study will receive an ultrasound exam with Hepatoscope to collect quantitative measurements related to the severity of liver steatosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver ultrasound | Device | Hepatoscope is a point of care ultraportable ultrasound device that is capable of conventional grayscale ultrasound imaging, of 2D transient elastography (imaging + liver stiffness measurement), and of quantitative ultrasound properties measurement (ultrasound attenuation, backscattering coefficient, sound speed) related to liver steatosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation with MRI PDFF | Spearman correlation coefficients between each Hepatoscope measurement (ATT, BSC and SOS) and MRI-PDFF measurements will be calculated. The confidence interval will be estimated with an alpha risk of 0,017 (Bonferroni adjustment, overal alpha risk of 0,05). Each correlation will be compared to the lowest acceptable threshold D = 0,50 with a Fisher Z test, with an alpha risk de 0,017. | At a maximum of 6 months from enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison with Fibroscan CAP | Spearman correlations between Hepatoscope measurements and MRI-PDFF will be compared to Spearman correlations between Fibroscan CAP measurements and MRI-PDFF. The 95% confidence interval of each correlation will be estimated and compared to each other using a Fisher Z test with an alpha risk of 0,05. | At a maximum of 6 months from enrollment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jerome Boursier, MD, PhD | Contact | +33 2 41 35 31 42 | jeboursier@chu-angers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Claude Cohen-Bacrie | E-Scopics | Study Director |
| Jerome Boursier, MD, PhD | University Hospital, Angers | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Angers | Recruiting | Angers | 49933 | France |
Only de-identified individual participant data may be shared, limited to data collected in CRF
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Cross sectional investigation
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| Beaujon University Hospital | Recruiting | Clichy | 92110 | France |
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| Pitie Salpetriere University Hospital | Not yet recruiting | Paris | 75013 | France |
|
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| D005234 | Fatty Liver |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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