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NCT02201472 Clinical Trial

Magnetic Resonance Elastography in Infants

Liver Disease Clinical Trial

— MREI  

Official title:
Magnetic Resonance Elastography in Infants

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02201472
Other study ID # 2014-3065
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 2014
Est. completion date August 2015

Study information
Verified date February 2017
Source Children's Hospital Medical Center, Cincinnati
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

MRI & MRE in infants

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.

Recruitment information / eligibility
Status Terminated
Enrollment 2
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Months
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• MRI with MRE
Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital Medical Center, Cincinnati

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