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Normal Liver Stiffness by MR Elastography

Determination of Normal Liver Stiffness by MR Elastography in Children

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03235414
Enrollment
101
Registered
2017-08-01
Start date
2018-02-19
Completion date
2020-07-24
Last updated
2026-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Diseases

Brief summary

Healthy children will be recruited to under Magnetic Resonance Imaging (MRI)along with MR elastography to determine normal liver stiffness values.

Detailed description

MR elastography (MRE) is playing a growing role in the non-invasive diagnosis and monitoring of liver disease in the pediatric population. There is, however, little data specific to the use of this technique in children with existing data and techniques largely extrapolated from adult studies. Existing studies suggest that liver stiffness values may be different between children and adults \[Etchell, Xanthakos\]. As such there is an unmet need for uniquely pediatric data in both healthy and diseased cohorts. To address the need for such data, the investigators plan a multi-site, prospective study of healthy pediatric (\<18 years of age) volunteers to determine normal liver stiffness measured by MR elastography across the range of MRI equipment.

Interventions

DEVICEMRI

Will receive a one time research MRI (MR elastography)

DIAGNOSTIC_TESTBlood draw

Will receive a one time blood draw to confirm healthy liver status

Sponsors

Children's Hospital Medical Center, Cincinnati
Lead SponsorOTHER
Massachusetts General Hospital
CollaboratorOTHER
Washington University School of Medicine
CollaboratorOTHER
Children's Hospital of Philadelphia
CollaboratorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 7-17 years * No documented history of liver diseases * English speaking

Exclusion criteria

* NPO less than 4 hours * Body mass index \<10th or \> 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

Design outcomes

Primary

MeasureTime frameDescription
Liver Stiffness30 minutesLiver stiffness is a measure of a mechanical property of tissue (stiffness). This can be measured non-invasively by MR elastography, a technique that involves applying an external vibration to the abdomen and measuring the progression of shear waves through the underlying liver using MRI. Purpose of the study was to determine normal (healthy) liver stiffness as measured by MRE

Secondary

MeasureTime frameDescription
Cross-platform Variability30 minutesTo assess for cross-platform (different MRI vendors) variability in normal MRI liver stiffness values
Cross-field Strength30 minutesTo assess cross-field strength (1.5T vs. 3T) variability in normal MRI liver stiffness values
Sex-related Differences30 minutesTo assess for sex-related (male vs. female) differences in normal MRI liver stiffness values

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORAndrew Trout, MD

Children's Hospital Medical Center, Cincinnati

Participant flow

Pre-assignment details

Of the 101 participants enrolled, 23 had exclusionary data and were not included in analysis. 7 had missing data which was not included in the final analysis.

Participants by arm

ArmCount
Normals
Healthy participants receive an MRI and a blood draw MRI: Will receive a one time research MRI (MR elastography) Blood draw: Will receive a one time blood draw to confirm healthy liver status
71
Total71

Baseline characteristics

CharacteristicNormals
Age, Categorical
<=18 years
71 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Age, Continuous12 years
Sex: Female, Male
Female
39 Participants
Sex: Female, Male
Male
32 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 101
other
Total, other adverse events
0 / 101
serious
Total, serious adverse events
0 / 101

Outcome results

Primary

Liver Stiffness

Liver stiffness is a measure of a mechanical property of tissue (stiffness). This can be measured non-invasively by MR elastography, a technique that involves applying an external vibration to the abdomen and measuring the progression of shear waves through the underlying liver using MRI. Purpose of the study was to determine normal (healthy) liver stiffness as measured by MRE

Time frame: During investigation

Population: Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data

ArmMeasureValue (MEDIAN)
Healthy ParticipantsLiver Stiffness2.1 kPa
Secondary

Cross-field Strength

To assess cross-field strength (1.5T vs. 3T) variability in normal MRI liver stiffness values

Time frame: During investigation

Population: Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data

ArmMeasureGroupValue (MEAN)Dispersion
Healthy ParticipantsCross-field Strength1.5T2.3 kPaStandard Deviation 0.4
Healthy ParticipantsCross-field Strength3T2.1 kPaStandard Deviation 0.4
Secondary

Cross-platform Variability

To assess for cross-platform (different MRI vendors) variability in normal MRI liver stiffness values

Time frame: During Investigation

Population: Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data

ArmMeasureGroupValue (MEAN)Dispersion
Healthy ParticipantsCross-platform VariabilityGE2.1 kPaStandard Deviation 0.5
Healthy ParticipantsCross-platform VariabilityPhilips2.3 kPaStandard Deviation 0.4
Healthy ParticipantsCross-platform VariabilitySiemens2.1 kPaStandard Deviation 0.2
Secondary

Sex-related Differences

To assess for sex-related (male vs. female) differences in normal MRI liver stiffness values

Time frame: During investigation

Population: Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data

ArmMeasureGroupValue (MEAN)Dispersion
Healthy ParticipantsSex-related DifferencesFemale2.2 kPaStandard Deviation 0.4
Healthy ParticipantsSex-related DifferencesMale2.2 kPaStandard Deviation 0.4

Source: ClinicalTrials.gov · Data processed: Jul 25, 2026