NCT05008263

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 17, 2021

Completed
Last Updated

August 17, 2021

Status Verified

June 1, 2021

Enrollment Period

1.5 years

First QC Date

June 23, 2021

Last Update Submit

August 16, 2021

Conditions

Liver FibrosesLiver Cirrhosis

Keywords

Liver fibrosisLiver cirrhosisLiver biopsyShear wave imagingDynamic liver scintigraphy

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • Comparison of radiological imaging tests between each other I

    Baseline only

  • Comparison of radiological imaging tests between each other II

    Baseline only

  • Comparison of radiological imaging tests between each other III

    Baseline only

Study Arms (1)

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)Diagnostic Test: Liver scintigraphy with 99mTc-mebrofenin

Interventions

Liver elastography (2D-SWE)DIAGNOSTIC_TEST

All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy.

Patients with viral chronic liver disease at primary diagnosis
Liver scintigraphy with 99mTc-mebrofeninDIAGNOSTIC_TEST

All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy.

Patients with viral chronic liver disease at primary diagnosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • chronic liver disease
  • signed informed consent
  • liver biopsy indicated by treating gastroenterologist/infectologist

You may not qualify if:

  • non-corrected blood coagulation tests
  • acute liver disease
  • age below 18 years or above 80 years
  • disagreement to participate in the study
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University

Vilnius, 211950810, Lithuania

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Algirdas E Tamosiunas, MD, PhD

    Vilnius University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2021

First Posted

August 17, 2021

Study Start

August 1, 2018

Primary Completion

January 31, 2020

Study Completion

January 31, 2020

Last Updated

August 17, 2021

Record last verified: 2021-06

Locations

LI(1)