Magnetic Resonance Elastography in Infants

Not Applicable

Terminated

• Conditions: Liver Disease
• Interventions: Device: MRI with MRE

• Registration Number: NCT02201472
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

MRI \& MRE in infants

Detailed Description

The purpose of the present pilot study is to determine the feasibility of using MRI and MRE to evaluate the liver in infants with suspected liver disease.

Study Timeline

• Study First Submitted: 2014-07-23
• Study First Submitted QC: 2014-07-25
• Study First Posted: 2014-07-28
• Study Start: 2014-08
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2017-02
• Results First Submitted: 2020-08-17
• Results First Submitted QC: 2020-08-17
• Last Update Submitted: 2020-08-17
• Results First Posted: 2020-09-01
• Last Update Posted: 2020-09-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Infants < 6 months of age
• Known liver disease based (liver enzymes, bilirubin, and/or GGT at least twice the upper limit of normal for age)
• Parental/LAR permission obtained

Exclusion Criteria

• Standard MRI exclusion criteria as set forth by the CCHMC Division of Radiology
• Severe coagulopathy (INR > 3 or platelets <50,000)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI with MRE	MRI with MRE	Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device

Primary Outcome Measures

Name	Time	Method
Feasibility of MRE to Provide Evaluable Images That Illustrate the Stiffness of Liver Parenchyma in an Infant Population	12 months	To determine the feasibility of MRE to provide evaluable images that illustrate the stiffness of liver parenchyma in an infant population.