Attenuation Imaging in Hepatic Steatosis

March 29, 2022 updated by: Hallym University Kangnam Sacred Heart Hospital

Noninvasive Assessment of Hepatic Steatosis by Using Attenuation Imaging in Children

For obese and normal-weight children, the investigators assess the diagnostic performance of attenuation imaging (ATI) in the detection of hepatic steatosis in children.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

120

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.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Obese and normal-weight children

Description

Inclusion Criteria:

  • BMI of 85th percentile or less

Exclusion Criteria:

  • congenital anomaly including heart, intestine, kidney
  • acute hepatitis
  • congenital hepatic anomaly

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obesity
BMI of 95 th percentile or more
Diagnostic test: Attenuation imaging in ultrasonography
Attenuation imaging in ultrasonography
Normal weight
BMI of 85 th percentile or less
Diagnostic test: Attenuation imaging in ultrasonography
Attenuation imaging in ultrasonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance of attenuation imaging
Time Frame: through study completion, an average of 1 year
The diagnostic performance of attenuation imaging in US in the detection of hepatic steatosis
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hallym University Kangnam Sacred Heart Hospital

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 Major Dates

Study Start (Anticipated)

April 14, 2022

Primary Completion (Anticipated)

December 14, 2022

Study Completion (Anticipated)

December 14, 2022

Study Registration Dates

First Submitted

March 18, 2022

First Submitted That Met QC Criteria

March 29, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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