MedTrace Logo

CT Liver Fat Fraction Quantification

NCT05676177 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-04-12

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

Ultra Low Dose CT

* 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

DIAGNOSTIC_TEST

Fat quantification MRI

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

Sponsors & Collaborators

  • Sheba Medical Center

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-29
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • Israel

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05676177 on ClinicalTrials.gov