Attenuation Imaging in Hepatic Steatosis

• Sponsor: Hallym University Kangnam Sacred Heart Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05302258
• Collaborator: (none)
• Enrollment: 120
• Anticipated Duration (Months): 8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hepatic Steatosis; Obesity, Childhood; Ultrasonography	Diagnostic Test: Attenuation imaging in ultrasonography

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Noninvasive Assessment of Hepatic Steatosis by Using Attenuation Imaging in Children
• Anticipated Study Start Date: Apr 14, 2022
• Anticipated Primary Completion Date: Dec 14, 2022
• Anticipated Study Completion Date: Dec 14, 2022

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Diagnostic performance of attenuation imaging [through study completion, an average of 1 year]

   The diagnostic performance of attenuation imaging in US in the detection of hepatic steatosis

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• BMI of 85th percentile or less

Exclusion Criteria:

• congenital anomaly including heart, intestine, kidney

• acute hepatitis

• congenital hepatic anomaly

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Hallym University Kangnam Sacred Heart Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hallym University Kangnam Sacred Heart Hospital
• ClinicalTrials.gov Identifier: NCT05302258
• Other Study ID Numbers: ATI
• First Posted: Mar 31, 2022
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Fatty Liver; Pediatric Obesity

Study Results

No Results Posted as of Mar 31, 2022