Trial Outcomes & Findings for Determination of Liver Stiffness in Chronic Liver Disease Patients by Acoustic Radiation Force Imaging (ARFI) Ultrasound (NCT NCT02652221)

Results Overview

The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

55 participants

Primary outcome timeframe

Within 24 hours

Results posted on

2017-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Study Cohort Acoustic Radiation Force Imaging Acoustic Radiation Force Imaging: ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness.
Overall Study STARTED	55
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Cohort n=55 Participants Acoustic Radiation Force Imaging Acoustic Radiation Force Imaging: ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness.
Age, Continuous	14 years STANDARD_DEVIATION 3.9 • n=55 Participants
Sex: Female, Male Female	24 Participants n=55 Participants
Sex: Female, Male Male	31 Participants n=55 Participants
Region of Enrollment United States	55 participants n=55 Participants
BMI	29.1 kg/m2 STANDARD_DEVIATION 8.7 • n=55 Participants

PRIMARY outcome

Timeframe: Within 24 hours

The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis

Outcome measures

Outcome measures
Measure	BMI <30 kg/m2 n=27 Participants Subset of study cohort with BMI \<30 kg/m2	BMI >30kg/m2 n=28 Participants Subset of study cohort with BMI 30 kg/m2 or more
Agreement in Measured Liver Stiffness Between ARFI and MRE Mean Stiffness by MRE	3.21 kPa	2.48 kPa
Agreement in Measured Liver Stiffness Between ARFI and MRE Mean Stiffness by ARFI	1.81 kPa	2.0 kPa

PRIMARY outcome

Timeframe: Within 24 hours

The investigators are seeking to define agreement between ARFI and MRE liver stiffness measurements obtained in the same patients on the same day to determine if the modalities can be used interchangeably for measurement of liver stiffness and prediction of significant liver fibrosis

Outcome measures

Outcome measures
Measure	BMI <30 kg/m2 n=27 Participants Subset of study cohort with BMI \<30 kg/m2	BMI >30kg/m2 n=28 Participants Subset of study cohort with BMI 30 kg/m2 or more
Agreement in Measured Liver Stiffness Between ARFI and MRE	0.61 Correlation Coefficient (rho)	0.07 Correlation Coefficient (rho)

Adverse Events

Study Cohort

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

Andrew T. Trout, MD

Cincinnati Children's Hospital Medical Center

Phone: 513-803-3004

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place