Liver FibrosesNCT05008263
Competitive Accuracy of Radiological Imaging Compared to Liver Biopsy in Patients With Liver Fibrosis
An observational study of Liver Fibroses and Liver Cirrhosis, run by Vilnius University at 1 site in Lithuania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Fibroses, Liver Cirrhosis
- What is being tested?
- Liver elastography (2D-SWE) and Liver scintigraphy with 99mTc-mebrofenin
- How many people
- 72 participants
- Where
- 1 siteLithuania
- Study dates
- 1 Aug 2018to 31 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary diagnosis of chronic viral liver disease who are referred treating gastroenterologist/infectologist for liver biopsy prior to treatment.
Who may be able to join
- chronic liver disease
- signed informed consent
- liver biopsy indicated by treating gastroenterologist/infectologist
Who cannot join
- non-corrected blood coagulation tests
- acute liver disease
- age below 18 years or above 80 years
- disagreement to participate in the study
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Liver Fibroses, Liver Cirrhosis
- Being tested
- Liver elastography (2D-SWE), Liver scintigraphy with 99mTc-mebrofenin
- Keywords
- Liver fibrosis, Liver cirrhosis, Liver biopsy, Shear wave imaging, Dynamic liver scintigraphy
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Liver elastography (2D-SWE); Diagnostic Test: Liver scintigraphy with 99mTc-mebrofenin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline only
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2021
- Study start1 Aug 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver FibrosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Algirdas E Tamosiunas, MD, PhD, Principal investigator, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05008263
- Sponsor's protocol ID
- 158200-18/7-1053-552
- Status last verified
- Jun 2021
- First submitted
- 23 Jun 2021
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Competitive Accuracy of Radiological Imaging Compared to Liver Biopsy in Patients With Liver Fibrosis
- ClinicalTrials.gov ID
- NCT05008263
- Acronym / sponsor ID
- 158200-18/7-1053-552
- Conditions
- Liver Fibroses, Liver Cirrhosis
- Keywords
- Liver fibrosis, Liver cirrhosis, Liver biopsy, Shear wave imaging, Dynamic liver scintigraphy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 17 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with viral chronic liver disease at primary diagnosis | – | Diagnostic Test: Liver elastography (2D-SWE), Diagnostic Test: Liver scintigraphy with 99mTc-mebrofeninPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary diagnosis of chronic viral liver disease who are referred treating gastroenterologist/infectologist for liver biopsy prior to treatment.
Key inclusion criteria (3 listed)
- chronic liver disease
- signed informed consent
- liver biopsy indicated by treating gastroenterologist/infectologist
Key exclusion criteria (5 listed)
- non-corrected blood coagulation tests
- acute liver disease
- age below 18 years or above 80 years
- disagreement to participate in the study
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Patients with viral chronic liver disease at primary diagnosis |
| Liver scintigraphy with 99mTc-mebrofeninAll patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy. | Diagnostic test | Patients with viral chronic liver disease at primary diagnosis |
Primary outcome
Ultrasound elastography comparison to histological examination of liver biopsy specimen
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
3 secondary outcomes
Comparison of radiological imaging tests between each other I
Time frame: Baseline only
Comparison of radiological imaging tests between each other II
Time frame: Baseline only
Comparison of radiological imaging tests between each other III
Time frame: Baseline only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Algirdas E Tamosiunas, MD, PhD principal investigator
Vilnius University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibroses and Liver Cirrhosis, run by Vilnius University at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound elastography comparison to histological examination of liver biopsy specimen (time frame: Baseline only). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.