Clinical trial NCT06051669: Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Liver Fibrosis
Fatty Liver
Lead sponsor: New Discovery LLC
Sponsor class: INDUSTRY
Collaborators: name: NYU Langone Health
name: Stanford University
name: Rush University
name: Baylor University
name: Wuxi Hisky Medical Technology Co Ltd
First posted: 2023-09-25
Enrollment: 418
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Liver Stiffness Measurement (LSM) value from iLivTouch and FibroScan detection
timeFrame: 6 months
measure: Ultrasound/Controlled Attenuation Parameters (UAP/CAP) from iLivTouch and FibroScan detection
timeFrame: 6 months
Secondary outcomes:
measure: To compare the success rate of the iLivTouch and FibroScan
timeFrame: 6 months
measure: To compare the number of effective examinations of iLivTouch and FibroScan
timeFrame: 6 months
measure: Liver stiffness measurement (LSM) and AST to Platelet Ratio Index (APRI)
timeFrame: 6 months
measure: Liver stiffness measurement (LSM) and Fibrosis-4 (FIB-4)
timeFrame: 6 months
measure: Liver stiffness measurement (LSM) and Steatosis-associated Fibrosis Estimator (SAFE) scores
timeFrame: 6 months
measure: Adverse events, serious events
timeFrame: 6 months
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford University
state: California
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: New York
country: United States
facility: NYU Langone
state: New York
city: Houston
country: United States
facility: Baylor University
state: Texas
Study officials:
affiliation: New York University Langone Health
name: Calvin Q. Pan
role: STUDY_CHAIR
References: