Trial Outcomes & Findings for Normal Liver Stiffness by MR Elastography (NCT NCT03235414)

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

101 participants

Primary outcome timeframe

During investigation

Results posted on

2020-09-16

Participant Flow

Participant milestones

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

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
Region of Enrollment United States	71 participants n=71 Participants

PRIMARY outcome

Timeframe: 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

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

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: 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

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

Outcome measures

Outcome measures
Measure	Healthy Participants n=71 Participants Healthy participants will undergo Magnetic Resonance Elastography Imaging of the liver
Cross-platform Variability GE	2.1 kPa Standard Deviation 0.5
Cross-platform Variability Philips	2.3 kPa Standard Deviation 0.4
Cross-platform Variability Siemens	2.1 kPa Standard Deviation 0.2

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Healthy Participants n=71 Participants Healthy participants will undergo Magnetic Resonance Elastography Imaging of the liver
Cross-field Strength 1.5T	2.3 kPa Standard Deviation 0.4
Cross-field Strength 3T	2.1 kPa Standard Deviation 0.4

SECONDARY outcome

Timeframe: 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

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

Outcome measures

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 events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Phone: 513-803-3004

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place