Magnetic Resonance Elastography in Infants

NCT02201472 | Terminated Results

• 1 other identifier: 2014-3065
• Study Type: interventional
• Target: 2
• Locations: 0 countries
• Sites: N/A

Brief Summary

MRI \& MRE in infants

Conditions

Liver Disease

Keywords

liver; mre; mri; neonatal; mr touch

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

MRI with MRE

EXPERIMENTAL

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

Device: MRI with MRE

Interventions

MRI with MRE DEVICE

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

MRI with MRE

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Severe coagulopathy (INR \> 3 or platelets \<50,000)

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

MeSH Terms

Conditions

Liver Diseases

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Limitations and 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.

Results Point of Contact

• Title: Dr. Stephanie Merhar
• Organization: Cincinnati Children's Hospital

stephanie.merhar@cchmc.org

513-803-5180

Study Officials

• Stephanie Merhar, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Magnetic resonance elastography on infants with suspected liver disease

Study Record Dates

• First Submitted: July 23, 2014
• First Posted: July 28, 2014
• Study Start: August 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 1, 2020
• Results First Posted: September 1, 2020

Record last verified: 2017-02