Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US

Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US: A Multicenter, Cross-sectional, and Prospective Study

This is a multi-center, cross-sectional, and prospective study that will recruit patients from multiple hospitals or outpatient clinics in the USA to the comparison of iLivTouch and FibroScan for the assessment of liver fibrosis and steatosis in adult patients.

Study Overview

• Status: Recruiting
• Conditions: Fatty Liver; Liver Fibrosis
• Intervention / Treatment: Device: iLivTouch; Device: FibroScan

Detailed Description

Clinical phase: Phase IV investigator-initiated study Study centers planned: Approximately 4 centers in different regions of the USA

Objectives:

1. Primary Objectives To evaluate the consistency of Liver Stiffness Measurement (LSM) and Ultrasound/Controlled Attenuation Parameters (UAP/CAP) between iLivTouch-FT9000 and FibroScan 530 devices.

2. Secondary Objectives

   1. To compare the operational features of the two devices, reflected in the success rate of examination and number of effective examinations.
   2. To compare LSM obtained from each device with liver stiffness estimated by APRI, FIB-4, and SAFE scores.
   3. The number of adverse events, serious events, and percentage of subjects with events will be calculated for AE, SAE, AE of special interest, and AE leading to study withdrawal.

• Study Type: Observational
• Enrollment (Estimated): 418

Contacts and Locations

• Study Contact: Name: Calvin Q Pan, Dr; Phone Number: (718) 888-7728; Email: Panc01@nyu.edu
• Study Contact Backup: Name: Hector Ye, PA; Phone Number: 17188880518; Email: hector.ye.pa@gmail.com

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94305
      • Not yet recruiting
      • Stanford University
      • Contact: Ray Kim, Dr
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Not yet recruiting
      • Rush University
      • Contact: Nancy Reau, Dr
  • New York
    • New York, New York, United States, 11355
      • Recruiting
      • NYU Langone
      • Contact: Calvin Q Pan, Dr
  • Texas
    • Houston, Texas, United States, 76798
      • Not yet recruiting
      • Baylor University
      • Contact: Prasun K Jalal, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The following conditions are considered as patient withdrawal from the current study:

• Patient withdrawal of informed consent at any time during the study;
• The lack of adherence to the protocol to complete the tests by two devices.

Description

Inclusion Criteria:

• a. Adults aged above 18 years old who have at least one indication for TE examination determined by the physicians;
• b. Patients who have test results for platelet count, ALT, AST, globulin, HBA1c, and total bilirubin (TBIL) levels within 60 days;
• c. Patients who are willing to participate in the clinical study and can sign ICF.

Exclusion Criteria:

• a. Excessive drinking history within 90 days: For women-140 grams of alcohol per week or more; For men-210 grams of alcohol per week or more;
• b. Patients with alanine aminotransferase (ALT) or aspartate aminotransferase AST >100 U/ml (or 2.5 × upper limit of normal (ULN) and/or total bilirubin (TBIL) > 1.8 mg/d (or >1.5 × ULN =1.2 mg/d);
• c. Patients with a history or current evidence of decompensated liver cirrhosis;
• d. Patients with various space-occupying tumors and cysts in the right liver;
• e. Patients with other serious systemically diseases or a history of malignant tumors;
• f. Patients with ascites;
• g. Patients with a non-healing wound on the right upper abdomen at this moment;
• h. Patients with intracavitary implantation of instruments;
• i. Pregnant women (urine pregnancy test should be performed for all women with child-bearing potential during screening);
• j. Any history of organ transplantation and existing functional grafts (except corneal or hair transplantation);
• k. Lack of or limited legal capacity.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
iLivTouch then FibroScan; Subjects in the Group "iLivTouch then FibroScan" will be measured using iLivTouch first and then FibroScan based on the randomization result.	Device: iLivTouch; The examination with iLivTouch will be performed in each subject following the sequence determined by the randomization results.; Device: FibroScan; The examination with FibroScan will be performed in each subject following the sequence determined by the randomization results.
FibroScan then iLivTouch; Subjects in the Group "FibroScan then iLivTouch" will be measured using FibroScan first and then iLivTouch based on the randomization result.	Device: iLivTouch; The examination with iLivTouch will be performed in each subject following the sequence determined by the randomization results.; Device: FibroScan; The examination with FibroScan will be performed in each subject following the sequence determined by the randomization results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver Stiffness Measurement (LSM) value from iLivTouch and FibroScan detection	Spearman correlation coefficients and 95% confidence interval will be calculated to analyze the correlation of the measurements (LSM) between iLivTouch-FT9000 and FibroScan 530 devices.	6 months
Ultrasound/Controlled Attenuation Parameters (UAP/CAP) from iLivTouch and FibroScan detection	Spearman correlation coefficients and 95% confidence interval will be calculated to analyze the correlation of the measurements (UAP/CAP) between iLivTouch-FT9000 and FibroScan 530 devices.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the success rate of the iLivTouch and FibroScan	The success rate of examination will be obtained from the percentage of patients who are successful in the test.	6 months
To compare the number of effective examinations of iLivTouch and FibroScan	The number of effective examinations will be obtained from the number of attempts to obtain the effective results.	6 months
Liver stiffness measurement (LSM) and AST to Platelet Ratio Index (APRI)	To compare LSM obtained from each device with liver stiffness estimated by APRI. Two liver fibrosis detection results based on LSM and APRI will be compared. The higher values mean more serious fibrosis.	6 months
Liver stiffness measurement (LSM) and Fibrosis-4 (FIB-4)	Two liver fibrosis detection results based on LSM and FIB-4 will be compared. FIB-4 refers to Age (years), AST Level (U/L), Platelet Count (10^9/L), ALT (U/L), with higher values mean more serious fibrosis.	6 months
Liver stiffness measurement (LSM) and Steatosis-associated Fibrosis Estimator (SAFE) scores	Two liver fibrosis detection results based on LSM and SAFE scores will be compared. The higher values mean more serious fibrosis.	6 months
Adverse events, serious events	The number of adverse events, serious events, and percentage of subjects with events will be calculated for AE, SAE, AE of special interest, and AE leading to study withdrawal.	6 months

Collaborators and Investigators

• Sponsor: New Discovery LLC
• Collaborators: NYU Langone Health; Stanford University; Baylor University; Rush University; Wuxi Hisky Medical Technology Co Ltd
• Investigators: Study Chair: Calvin Q. Pan, New York University Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2023
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 20, 2023
• First Posted (Actual): September 25, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Fatty Liver; Liver Cirrhosis
• Other Study ID Numbers: ILT-US-2023-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No