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| Name | Class |
|---|---|
| Echosens | INDUSTRY |
| Institut National de la Santé Et de la Recherche Médicale, France | OTHER_GOV |
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Hypothesis of this study is the existence of a relation between parameters measured by FibroScan® FS 502 according to our non invasive method and liver steatosis condition.
This proof of concept validation is made up of two steps:
Experimental procedures consist in:
Diagnosis of liver lipid overload (named liver steatosis), unrelated to alcohol consumption, still mainly based on histological exam of the liver. An histological continuity exists going from clean liver steatosis (Non Alcoholic Fatty Liver Disease, NAFLD) to steatohepatitis with signs of inflammation and tissue fibrosis (Non Alcoholic Steato-Hepatitis, NASH). It's now well-known that disease can evolve to cirrhosis and its complications.
Hypothesis of this study is the existence of a relation between parameters measured by FibroScan® FS 502 according to our non invasive method and liver steatosis condition.
This proof of concept validation is made up of two steps:
Measures on healthy volunteers enable to do an intra-operator reproductibility analysis, a study of an age effect and a search of potential mechanic aging of the liver.
Experimental procedures consist in:
The final aim of this study is to propose a device enable medical community to do in vivo hepatic rheology observation, highly correlated to liver lipid overload. After industrialization of this innovation, this diffusion could making easier patients follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibroscan exam | Experimental | Step 1: feasibility study of the method on 10 healthy volunteers Step 2: diagnosis study on 50 healthy volunteers (25 between 18-30 years-old and 25 between 40-65 years-old) and on 25 patients whom cares including an hepatic biopsy et whom the histological answer is clean steatosis (NAFLD). Experimental procedures consist in:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibroscan | Device | Three series oh independent measures Measure done with Fibroscan will be preceded by tracking ultrasonography. |
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| Measure | Description | Time Frame |
|---|---|---|
| Viscosity in Pa.s | Digital files recorded by medical device will be mathematically processed for extracting elasticity G' and viscosity G'' curves in accordance with the frequency. These curves use to identify the 5 parameters: mu(M), eta(M), alpha, mu(V), eta(V); which describe visco-elasticity variations with frequency thanks to an Matlab algorithm | One day |
| Elasticity in kPa | Digital files recorded by medical device will be mathematically processed for extracting elasticity G' and viscosity G'' curves in accordance with the frequency. These curves use to identify the 5 parameters: mu(M), eta(M), alpha, mu(V), eta(V); which describe visco-elasticity variations with frequency thanks to an Matlab algorithm | One day |
| Measure | Description | Time Frame |
|---|---|---|
| Reproductibility quantification in arbitrary unit | The 5 estimated parameters (which describe visco-elasticity) will be used to quantify the medical device reproductibility | through study completion, an average of 2 years |
| Age in years |
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Inclusion Criteria:
Healthy subjects - Steps 1 and 2
Patients with liver steatosis - Step 2
Exclusion Criteria:
Healthy subjects - Step 1
Healthy subjects - Step 2
Healthy subjects - Steps 1 and 2
Patients with liver steatosis - Step 2
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| Name | Affiliation | Role |
|---|---|---|
| Frederic PATAT, MD, PhD | CHRU TOURS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Tours | Tours | 37044 | France |
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| Label | URL |
|---|---|
| Clinical Investigation Center - Technological Innovations | View source |
| University Hospital of Tours | View source |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| Blood test for biological assessment of liver function | Biological | Blood test for biological assessment of liver function |
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| MRI | Device | Liver MRI |
|
The 5 estimated parameters (which describe visco-elasticity) and the age oh the healthy volunteers wil be used to study an age effect
| through study completion, an average of 2 years |
| Liver signal intensity changes in decibel | Adiposis charge will be assessed by measure of liver signal intensity decrease on T1 sequence in phase opposition compared to in phase signal, after correction by iron quantity | through study completion, an average of 2 years |