CT Liver Fat Fraction Quantification

NCT05676177 | Unknown

• 1 other identifier: 9785-22-SMC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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").

Conditions

Non-Alcoholic Fatty Liver Disease; Steatosis of Liver

Outcome Measures

Primary Outcomes (1)

• Developing AI model of liver fat fraction assessment on data obtained from ultra-low dose CT, using MRI data as a standard of reference

  The investigators will 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 NAFLD, compared to MRI which serves as the standard of reference. The MRI data will be extracted from the dual-echo scan, which can produce an MRI-based liver fat-fraction, and this data will be then used to create an AI CT model. The AI model will be developed to be able to accurately produce an exact quantification of the liver fat fraction (exact percentage) on ultra-low dose CT.

  Through study completion, up to 24 months

Secondary Outcomes (1)

• External validation of the AI CT liver fat fraction model using a second participant group not included in the development of the AI-based CT model

  Through study completion, up to 24 months

Study Arms (1)

Main study arm

EXPERIMENTAL

All consenting participants will be invited to the radiology department during the medical screening rounds or at a different day (at their convenience). They will be scanned on both MRI and CT using dedicated protocols. Both scans will be conducted at the same day within a time-frame of 6 hours of each other. No follow up visit will be required. MRI would be performed on a 3 Tesla magnet using a dedicated short protocol consisting of axial and coronal T2-weighted scans for anatomic assessment, and a dual-echo scan to assess for liver fat. The scan time would be less than 10 minutes. CT scans will be performed using a single CT device. Ultra-low dose dual energy CT (ULD-DECT) scanning protocol parameters liver fat measurement (estimated scan time - less than 2 minutes).

Diagnostic Test: Ultra Low Dose CT; Diagnostic Test: Fat quantification MRI

Interventions

Ultra Low Dose CT DIAGNOSTIC_TEST

* Two immediately consecutive scans with either one or two breath-holds * First scan (ULD\_DECT\_1) 140 kilovolt peak (kVp) - fixed current 10 or 20 milliampere (mA) (if body mass index (BMI)\>30), that is 5 or 10 mAs * Second scan (ULD\_DECT\_2) 80 kVp - fixed current 20 or 40 mA (if BMI\>30), that is 10 or 20 mAs

Main study arm

Fat quantification MRI DIAGNOSTIC_TEST

Dual echo scans, as well as proton density fat fraction (PDFF) scans, will be performed to assess liver fat fraction

Main study arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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. 12-14
• No 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Prof. Noam Tau

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Radiologist and Primary Investigator

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: January 9, 2023
• Study Start: January 29, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)