NCT03957070

Brief Summary

Evaluate the feasibility of the Liver Incyte system for liver elasticity measurement in healthy volunteers and patients with liver fibrosis. To evaluate the discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan measurements.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2019

Typical duration for not_applicable

Geographic Reach
2 countries

2 active sites

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

February 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

November 8, 2021

Status Verified

November 1, 2021

Enrollment Period

2.2 years

First QC Date

April 3, 2019

Last Update Submit

November 4, 2021

Conditions

Liver FibrosisLiver Steatosis

Keywords

liverultrasound elastography

Outcome Measures

Primary Outcomes (1)

  • Discrimination of healthy from patients with liver fibrosis

    The discriminatory ability of elasticity measurements generated by Liver Incyte for healthy volunteers versus patients with liver fibrosis in comparison to FibroScan measurements. An receiver operating characteristic (ROC) curve using final Liver Incyte elasticity measurement as a predictor of healthy versus fibrotic (HCV/NASH) will be constructed with accompanying 95% confidence interval for the area under the curve (AUC). The AUC and 95% confidence intervals for the FibroScan device will be calculated.

    6 months

Secondary Outcomes (1)

  • Safety of the device as measured by rate of adverse events

    6 months

Other Outcomes (2)

  • Agreement between Liver Incytes and MRI elastography measurements

    6 months

  • Correlation between Liver Incytes and MRI elastography measurements

    6 months

Study Arms (1)

Liver Incyte

EXPERIMENTAL

Patients with successfully treated HCV, or NASH Healthy volunteers with no history of liver disease. Patients and Volunteers will be scanned with FibroScan and Liver Incyte.

Device: Liver Incyte

Interventions

Liver IncyteDEVICE

Ultrasound elasticity imaging

Liver Incyte

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any sex, ages 19-75 years inclusively
  • Individuals with a history of chronic Hepatitis C (HCV) or non-alcoholic steatohepatitis (NASH). Patients with history of Hepatitis C must have completed treatment and achieved Sustained viral response at 12 weeks (SVR12).
  • Previous FibroScan measurement (within the last 13 months) between 8 kilopascals and 35 kilopascals.
  • Able to understand the informed consent form, study procedures and willing to participate in study

You may not qualify if:

  • Unable to achieve SVR12 with previous antiviral treatment for HCV
  • Multiple (\>1) liver disease diagnoses within the past 12 months
  • Co-infection with another Hepatitis virus or Human Immunodeficiency Virus (HIV), last testing within past 5 years
  • Documented or known ascites
  • Documented or known portal hypertension
  • BMI greater than 35 kg/m2 (30 kg/m2 for optional MRE participants)
  • If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding
  • Individuals with history of persistent ethanol abuse (alcohol consumption exceeding 2 standard drinks per day on average \[1 standard drink = 10 grams of alcohol\])
  • Individuals with implanted electrical devices such as pacemakers, internal defibrillators, cochlear implants and nerve stimulators.
  • Individuals with surgically removed gallbladder (for optional MRE procedure only)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

LAIR

Vancouver, British Columbia, V5Z 1H2, Canada

Location

Related Publications (1)

  • Curry MP, Tam E, Schneider C, Abdelgelil N, Hassanien T, Afdhal NH. The Use of Noninvasive Velacur(R) for Discriminating between Volunteers and Patients with Chronic Liver Disease: A Feasibility Study. Int J Hepatol. 2024 Jan 17;2024:8877130. doi: 10.1155/2024/8877130. eCollection 2024.

    PMID: 38274398DERIVED

MeSH Terms

Conditions

Liver CirrhosisFatty Liver

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2019

First Posted

May 21, 2019

Study Start

February 1, 2019

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

November 8, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(1)