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

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.

Study Overview

• Status: Completed
• Conditions: Liver Cirrhosis; Liver Fibroses
• Intervention / Treatment: Diagnostic test: Liver elastography (2D-SWE); Diagnostic test: Liver scintigraphy with 99mTc-mebrofenin

• Study Type: Observational
• Enrollment (Actual): 72

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, 211950810
    • Vilnius University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with primary diagnosis of chronic viral liver disease who are referred treating gastroenterologist/infectologist for liver biopsy prior to treatment.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with viral chronic liver disease at primary diagnosis; 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); All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy.; Diagnostic test: Liver scintigraphy with 99mTc-mebrofenin; All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Vilnius University
• Investigators: Principal Investigator: Algirdas E Tamosiunas, MD, PhD, Vilnius University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Liver cirrhosis; Liver fibrosis; Liver biopsy; Shear wave imaging; Dynamic liver scintigraphy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Hematinics; Liver Extracts; Technetium Tc 99m mebrofenin
• Other Study ID Numbers: 158200-18/7-1053-552

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No