MREI: Magnetic Resonance Elastography in Infants

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02201472
• Collaborator: (none)
• Enrollment: 2
• Arm: 1
• Duration (Months): 12

Study Details

Study Description

Brief Summary

MRI & MRE in infants

Condition or Disease	Intervention/Treatment	Phase
Liver Disease	Device: MRI with MRE	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Magnetic resonance elastography on infants with suspected liver diseaseMagnetic resonance elastography on infants with suspected liver disease
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Magnetic Resonance Elastography in Infants
• Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 6 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Children's Hospital Medical Center, Cincinnati

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT02201472
• Other Study ID Numbers: 2014-3065
• First Posted: Jul 28, 2014
• Last Update Posted: Sep 1, 2020
• Last Verified: Feb 1, 2017

• Keywords provided by Children's Hospital Medical Center, Cincinnati: liver; mre; mri; neonatal; mr touch
• Additional relevant MeSH terms: Liver Diseases

Study Results

Participant Flow

Arm/Group Title	MRI With MRE
Arm/Group Description	Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device
Period Title: Overall Study
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	MRI With MRE
Arm/Group Description	Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device
Overall Participants	0
Age () []
<=18 years
Between 18 and 65 years
>=65 years
Age (months) []
Sex: Female, Male () []
Female
Male
Race and Ethnicity Not Collected () []
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

There were too few eligible candidates that clinically would benefit enough to justify the potential risk of being removed from the unit and undergoing MRE in a Radiology department scanner, so the study was terminated with only 2 patients enrolled.

Arm/Group Title	MRI With MRE
Arm/Group Description	Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device
Measure Participants	0

Adverse Events

Time Frame	1 year
Arm/Group Title	MRI With MRE
Arm/Group Description	Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device
All Cause Mortality
	MRI With MRE
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	MRI With MRE
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	MRI With MRE
	Affected / at Risk (%)	# Events
Total	0/2 (0%)

Limitations/Caveats

Due to difficulty with finding neonates who met the inclusion/exclusion criteria who were safe to leave the NICU and go to the Radiology department, the study was terminated and data from the 2 participants enrolled was not analyzed.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.