RECRUITING

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-09-24

Study Completion:2025-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06051669

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Calvin Q Pan, Dr

CONTACT

(718) 888-7728

Panc01@nyu.edu

Hector Ye, PA

CONTACT

17188880518

hector.ye.pa@gmail.com

Principal Investigator

Calvin Q. Pan

STUDY_CHAIR

New York University Langone Health

Study Locations (Sites)

Stanford University

Redwood City, California, 94305

United States

Rush University

Chicago, Illinois, 60612

United States

NYU Langone

New York, New York, 11355

United States

Baylor University

Houston, Texas, 76798

United States

Collaborators and Investigators

Sponsor: New Discovery LLC

Calvin Q. Pan, STUDY_CHAIR, New York University Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-24

Study Completion Date2025-03

Study Record Updates

Study Start Date2023-09-24

Study Completion Date2025-03

Terms related to this study

Additional Relevant MeSH Terms

Liver Fibrosis
Fatty Liver