Magnetic Resonance Elastography in Infants (MREI)

August 17, 2020 updated by: Children's Hospital Medical Center, Cincinnati
MRI & MRE in infants

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

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

No older than 6 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI with MRE
Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device
Device: MRI with MRE
Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Children's Hospital Medical Center, Cincinnati

Investigators

  • Principal Investigator: Stephanie Merhar, MD, Children's Hospital Medical Center, Cincinnati

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

August 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

July 23, 2014

First Submitted That Met QC Criteria

July 25, 2014

First Posted (Estimate)

July 28, 2014

Study Record Updates

Last Update Posted (Actual)

September 1, 2020

Last Update Submitted That Met QC Criteria

August 17, 2020

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-3065

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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