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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05008263

Enrollment

Registered

2021-08-17

Start date

2018-08-01

Completion date

2020-01-31

Last updated

2021-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Liver Fibroses

Keywords

Liver fibrosis, Liver cirrhosis, Liver biopsy, Shear wave imaging, Dynamic liver scintigraphy

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.

Interventions

DIAGNOSTIC_TESTLiver elastography (2D-SWE)

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

DIAGNOSTIC_TESTLiver scintigraphy with 99mTc-mebrofenin

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Ultrasound elastography comparison to histological examination of liver biopsy specimen	Baseline only	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.
Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen I	Baseline only	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.
Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen II	Baseline only	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.
Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen III	Baseline only	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.

Secondary

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

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026