Competitive Accuracy of Radiological Imaging Compared to Liver Biopsy in Patients With Liver Fibrosis

Study Overview
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Brief Summary
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The study Competitive Accuracy of Radiological Imaging Compared to Liver Biopsy in Patients With Liver Fibrosis is designed to test the accuracy of non-interventional radiological imaging and compare its results with the gold standard liver biopsy. This is prospective non-randomized single patient group study.

Official Title
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Competitive Accuracy of Radiological Imaging Compared to Liver Biopsy in Patients With Liver Fibrosis

Conditions
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Liver Fibroses, Liver Cirrhosis

Intervention / Treatment
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* Diagnostic Test: Liver elastography (2D-SWE)
* Diagnostic Test: Liver scintigraphy with 99mTc-mebrofenin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic liver disease signed informed consent liver biopsy indicated by treating gastroenterologist/infectologist Exclusion Criteria: non-corrected blood coagulation tests acute liver disease age below 18 years or above 80 years disagreement to participate in the study pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with viral chronic liver disease at primary diagnosis<br>Patients with primary diagnosis of viral hepatitis B and hepatitis C who was referred for liver biopsy. All patients underwent liver shear wave elastography and dynamic liver scintigraphy evaluating liver physical and functional changes shortly prior to liver biopsy procedure. | Diagnostic Test: Liver elastography (2D-SWE)<br>* All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy.<br>Diagnostic Test: Liver scintigraphy with 99mTc-mebrofenin<br>* All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound elastography comparison to histological examination of liver biopsy specimen | Liver stiffness measured by ultrasound elastography (2D-SWE) in kPa is compared to histological examination of liver biopsy specimen at a single time point before initiating antiviral treatment. | Baseline only | 
| Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen I | Dynamic liver scintigraphy with 99mTc-mebrofenin parameter liver clearance (%/min/m2) is compared to histological examination of liver biopsy specimen at a single time point before initiating antiviral treatment. | Baseline only | 
| Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen II | Dynamic liver scintigraphy with 99mTc-mebrofenin parameter uptake time (min.) is compared to histological examination of liver biopsy specimen at a single time point before initiating antiviral treatment. | Baseline only | 
| Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen III | Dynamic liver scintigraphy with 99mTc-mebrofenin parameter liver excretion (30 min./peak ratio) is compared to histological examination of liver biopsy specimen at a single time point before initiating antiviral treatment. | Baseline only | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of radiological imaging tests between each other I | Liver stiffness measured by ultrasound elastography (2D-SWE) in kPa is compared to liver clearance measured by dynamic liver scintigraphy with 99mTc-mebrofenin. | Baseline only | 
| Comparison of radiological imaging tests between each other II | Liver stiffness measured by ultrasound elastography (2D-SWE) in kPa is compared to tracer excretion measured by dynamic liver scintigraphy with 99mTc-mebrofenin. | Baseline only | 
| Comparison of radiological imaging tests between each other III | Liver stiffness measured by ultrasound elastography (2D-SWE) in kPa is compared to tracer uptake time measured by dynamic liver scintigraphy with 99mTc-mebrofenin. | Baseline only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver fibrosis, Liver cirrhosis, Liver biopsy, Shear wave imaging, Dynamic liver scintigraphy