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Enrolling By Invitation
NCT05676177
CT Liver Fat Fraction Quantification
Conditions: Non-Alcoholic Fatty Liver Disease, Steatosis of Liver
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 150
Sponsor: Sheba Medical Center
Location: Israel
Summary
Our aim is to develop an AI based tool to use ultra-low dose CT in two separate energy levels using a single-energy CT machine to quantify liver fat in individuals at risk for having non-alcoholic fatty liver disease (NAFLD), compared to MRI which serves as the standard of reference.Secondary aim of our study is to validate the developed artificial intelligence (AI)-based model on a second group of participants ("external validation").
Eligibility Criteria
Inclusion Criteria:Adult patients (age ≥18 years)At risk for hepatic steatosis (defined as at least one of the followings: age >50 years, over weight (BMI>25), impaired fasting glucose or impaired glucose tolerance, T2DM, gestational diabetes, hyperlipidemia, hypertension, elevated liver enzymes, family history of steatosis or cirrhosis, increased liver span per medical examination, increased ferritin levels and the patatin-like phospholipase domain-containing 3 polymorphism), as decided by the treating endocrinologist in our institute's Medical screening department.
12-14No history of malignancy involving the liver.No known risk factors for hepatic iron deposition (multiple prior blood transfusions, known hemochromatosis).Subjects able to understand study procedures and provide informed consent.Subjects able to hold their breath during CT and MRI scans.Exclusion Criteria:Patients younger than 18 years.Patients with risk factors from hepatic iron deposition (multiple prior blood transfusions, known hemochromatosis).Patients with known malignancy that involves the liver.Patients unable to hold their breath for both CT and MRI.Patients with severe claustrophobia.Patients with implanted devices of shrapnel.Pregnant people
Source: ClinicalTrials.gov (NCT05676177). StuddyBuddy aggregates publicly available trial information.