Trial Outcomes & Findings for Normal Liver Stiffness by MR Elastography (NCT NCT03235414)
NCT ID: NCT03235414
Last Updated: 2026-07-24
Results Overview
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
COMPLETED
NA
101 participants
30 minutes
2026-07-24
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
101
|
|
Overall Study
COMPLETED
|
101
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data
Baseline characteristics by cohort
| Measure |
Normals
n=71 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
71 Participants
n=71 Participants • Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=71 Participants • Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data
|
|
Age, Categorical
>=65 years
|
0 Participants
n=71 Participants • Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data
|
|
Age, Continuous
|
12 years
n=71 Participants • Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data
|
|
Sex: Female, Male
Female
|
39 Participants
n=71 Participants • Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data
|
|
Sex: Female, Male
Male
|
32 Participants
n=71 Participants • Healthy Participants-Of the 101 participants enrolled 78 had no exclusionary data after completion of the single time point study. 7 had missing data
|
PRIMARY outcome
Timeframe: 30 minutesPopulation: Healthy Participants-Of the 101 participants enrolled, 23 had exclusionary data and were not included in analysis. 7 had missing data which did not allow for complete analysis, thus the data was not included in the final analysis.
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
Outcome measures
| Measure |
Healthy Participants
n=71 Participants
Healthy participants will undergo Magnetic Resonance Elastography Imaging of the liver
|
|---|---|
|
Liver Stiffness
|
2.1 kPa
Interval 1.9 to 2.3
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: Healthy Participants-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.
To assess for cross-platform (different MRI vendors) variability in normal MRI liver stiffness values
Outcome measures
| Measure |
Healthy Participants
n=71 Participants
Healthy participants will undergo Magnetic Resonance Elastography Imaging of the liver
|
|---|---|
|
Cross-platform Variability
Philips
|
2.3 kPa
Standard Deviation 0.4
|
|
Cross-platform Variability
Siemens
|
2.1 kPa
Standard Deviation 0.2
|
|
Cross-platform Variability
GE
|
2.1 kPa
Standard Deviation 0.5
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: Healthy Participants-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.
To assess cross-field strength (1.5T vs. 3T) variability in normal MRI liver stiffness values
Outcome measures
| Measure |
Healthy Participants
n=71 Participants
Healthy participants will undergo Magnetic Resonance Elastography Imaging of the liver
|
|---|---|
|
Cross-field Strength
3T
|
2.1 kPa
Standard Deviation 0.4
|
|
Cross-field Strength
1.5T
|
2.3 kPa
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 30 minutesPopulation: Healthy Participants-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.
To assess for sex-related (male vs. female) differences in normal MRI liver stiffness values
Outcome measures
| Measure |
Healthy Participants
n=71 Participants
Healthy participants will undergo Magnetic Resonance Elastography Imaging of the liver
|
|---|---|
|
Sex-related Differences
Female
|
2.2 kPa
Standard Deviation 0.4
|
|
Sex-related Differences
Male
|
2.2 kPa
Standard Deviation 0.4
|
Adverse Events
Healthy Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Andrew Trout
Cincinnati Children's Hospital Medical Center; Department of Radiology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place