Liver Disease
Conditions
Keywords
liver, mre, mri, neonatal, mr touch
Brief summary
MRI & MRE in infants
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.
Interventions
DEVICEMRI with MRE
Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Magnetic resonance elastography on infants with suspected liver disease
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Months
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MRI With MRE 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 | 0 |
| Total | 0 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 2 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 2 |
| other Total, other adverse events | 0 / 2 |
| serious Total, serious adverse events | 0 / 2 |
Outcome results
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.
Time frame: 12 months
Population: 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.