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

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.

• iLivTouch (Device): The examination with iLivTouch will be performed in each subject following the sequence determined by the randomization results.
• FibroScan (Device): The examination with FibroScan will be performed in each subject following the sequence determined by the randomization results.

Primary outcomes

• Liver Stiffness Measurement (LSM) value from iLivTouch and FibroScan detection [6 months]: 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.
• Ultrasound/Controlled Attenuation Parameters (UAP/CAP) from iLivTouch and FibroScan detection [6 months]: 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.

Secondary outcomes

• To compare the success rate of the iLivTouch and FibroScan [6 months]: The success rate of examination will be obtained from the percentage of patients who are successful in the test.
• To compare the number of effective examinations of iLivTouch and FibroScan [6 months]: The number of effective examinations will be obtained from the number of attempts to obtain the effective results.
• Liver stiffness measurement (LSM) and AST to Platelet Ratio Index (APRI) [6 months]: 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.
• Liver stiffness measurement (LSM) and Fibrosis-4 (FIB-4) [6 months]: 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.
• Liver stiffness measurement (LSM) and Steatosis-associated Fibrosis Estimator (SAFE) scores [6 months]: Two liver fibrosis detection results based on LSM and SAFE scores will be compared. The higher values mean more serious fibrosis.
• Adverse events, serious events [6 months]: 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.

Sex: All, ages: 18 Years to any

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.

• Calvin Q. Pan, Study chair, NYU Langone Health