Magnetic Resonance Elastography in Infants

NCT ID: NCT02201472

Last Updated: 2020-09-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-08-31

Brief Summary

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MRI \& MRE in infants

Detailed Description

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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.

Conditions

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Liver Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Magnetic resonance elastography on infants with suspected liver disease
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MRI with MRE

Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device

Group Type EXPERIMENTAL

MRI with MRE

Intervention Type DEVICE

Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device

Interventions

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MRI with MRE

Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device

Intervention Type DEVICE

Eligibility Criteria

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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

* Severe coagulopathy (INR \> 3 or platelets \<50,000)
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Stephanie Merhar, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Other Identifiers

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2014-3065

Identifier Type: -

Identifier Source: org_study_id

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