N/A
N=101
Normal Liver Stiffness by MR Elastography
Liver Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03235414 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Liver Stiffness — 2.1 kPa
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MRI (Device); Blood draw (Diagnostic_test)
- Age
- Pediatric · 7+ yrs
- Sex
- All
- Sponsor
- Children's Hospital Medical Center, Cincinnati
- Primary completion
- Jun 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Liver Stiffness |
2.1 | — |
| SECONDARY Cross-platform Variability |
2.1; 2.3; 2.1 | — |
| SECONDARY Cross-field Strength |
2.3; 2.1 | — |
| SECONDARY Sex-related Differences |
2.2; 2.2 | — |
Summary
Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR elastography to determine normal liver stiffness values.
Eligibility Criteria
Inclusion Criteria
- Age 7-17 years
- No documented history of liver diseases
- English speaking
Exclusion Criteria
- NPO less than 4 hours
- Body mass index 85th percentile for age
- Documented history of liver disease
- Pregnancy
- Inability to lie still for duration of the MRI
- Inability to breath hold for the duration of the 15-20 second MR elastography sequence
- Standard contraindication to MRI (implanted hardware, etc.)
- Requirement of sedation or general anesthesia for MRI
- Abnormality of any measured liver function test
- Liver fat fraction >5% by MRI PDFF
Data sourced from ClinicalTrials.gov (NCT03235414). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.