Non-invasive Liver Screening Using FibroScan Device for Liver Disease Patients for the Steatosis/Fibrosis Database

NCT ID: NCT02897908

Last Updated: 2025-03-28

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-28
• Study Completion Date: 2026-12-31

Brief Summary

The primary goal of this study is to establish a database of people with varying levels of hepatic fibrosis and various etiologies of liver disease for use in future research protocols.

Detailed Description

The Fibroscan device will determine liver stiffness as well as the amount of fat through another application on the machine called controlled attenuation parameter or Controlled Attenuation Parameters (CAP). The liver stiffness measurements are then translated into a score that tells how much liver fibrosis or fat is present. Patients identified with potential for fatty liver or specific liver-related diseases causing fibrosis would be approached for a voluntary FibroScan measurement. From these patients, the investigators will collect information related to demographics, disease history, medical comorbidities, social history, laboratory and radiologic parameters. This information, along with clinical data associated with the patient will be placed in a database for use in identifying potential subjects for future trials.

Conditions

Disease of Liver and Bile Duct

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

liver fibrosis and steatosis

measurements of liver fibrosis and steatosis will be obtained using Vibration controlled transient elastography FDA approved device- FibroScan for the purpose of building a data base of potential subjects for future research.

vibration controlled transient elastography (VCTE)

Intervention Type: PROCEDURE

Once on the examination table, the subject will be instructed to place the right arm under their head and to cross their right ankle over the left ankle. The subject will then be asked to slightly bend to the left side to open the intercostal space. Subsequently, a handheld probe is placed in the intercostal space overlaying the right hepatic lobe. The velocity of returning shear waves, measured at a depth of 25-65 mm, is converted into a liver stiffness measurement (LSM). The LSM obtained from a given VCTE exam is the median value of at least 10 successful measurements. This information, along with clinical data associated with the patient will be placed in a database for use in identifying potential subjects for future trials.

Interventions

vibration controlled transient elastography (VCTE)

Once on the examination table, the subject will be instructed to place the right arm under their head and to cross their right ankle over the left ankle. The subject will then be asked to slightly bend to the left side to open the intercostal space. Subsequently, a handheld probe is placed in the intercostal space overlaying the right hepatic lobe. The velocity of returning shear waves, measured at a depth of 25-65 mm, is converted into a liver stiffness measurement (LSM). The LSM obtained from a given VCTE exam is the median value of at least 10 successful measurements. This information, along with clinical data associated with the patient will be placed in a database for use in identifying potential subjects for future trials.

Intervention Type: PROCEDURE

Other Intervention Names

fibroscan

Eligibility Criteria

Inclusion Criteria

• Subjects with known, or suspected risk factors for steatosis (fat) or hepatic fibrosis
• Subjects who have been previously diagnosed with Non-Alcoholic Steatohepatitis (NASH) but who do not have current steatosis (fat) or fibrosis scoring
• Subjects who have other known liver diseases ie: HCV

Exclusion Criteria

• Patients less than 18 years of age
• Pregnancy
• Patients that do not want to be contacted for consideration in future research studies.
• Patients diagnosed with ascites or peritoneal dialysis
• Body mass index (BMI) ≥40

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kaleida Health

OTHER

Sponsor Role: collaborator

State University of New York at Buffalo

OTHER

Sponsor Role: lead

Responsible Party

Ajay Chaudhuri

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Conventus Medical Office Building

Buffalo, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ajay Chaudhuri, MD

Role: CONTACT

achaudhu@buffalo.edu

716-907-1916

Andrew Talal, MD

Role: CONTACT

ahtalal@buffalo.edu

716-888-4737

Facility Contacts

Ajay Chaudhuri, MD

Role: primary

achaudhu@buffalo.edu

716-907-1916

Other Identifiers

FibroScan

Identifier Type: -

Identifier Source: org_study_id