Trial Outcomes & Findings for Ultrasound Based Acoustic Radiation Force Impulse Imaging (NCT NCT01781208)
NCT ID: NCT01781208
Last Updated: 2016-10-21
Results Overview
Tissue shear wave speed is positively correlated to a material's/tissue's stiffness and can be noninvasively measured by ultrasound. The relationship between liver shear wave speed and liver histologic fibrosis score were assessed using 2 different ultrasound methods. Liver shear wave speed as obtained using 2 different ultrasound methods served as our primary outcome measures. Note, the histologic scoring system (Ishak) ranged from 0 to 6, where 0 = no fibrosis and 6 = cirrhosis.
COMPLETED
NA
62 participants
10 minutes
2016-10-21
Participant Flow
Pediatric patients aged 18 and younger were scheduled for a liver biopsy at a large pediatric hospital between 2012 and 2014. A total of 62 patients were recruited and enrolled. Patients and their parents gave consent/assent for the study.
Participant milestones
| Measure |
Ultrasound-based Acoustic Radiation Force Impulse (ARFI)
62 children undergoing clinically ordered ultrasound-directed percutaneous core needle liver biopsy were included. Biopsy was performed for known or suspected (non-neoplastic) liver disease. (One child did not undergo a liver biopsy, so was ineligible and not included in the above total.)
The patients received an additional ultrasound for research purposes that utilized a technique known as ARFI. ARFI, or Acoustic Radiation Force Impulse, uses a transducer which directs sound waves again the liver to measure the stiffness of the tissues.
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|---|---|
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Overall Study
STARTED
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62
|
|
Overall Study
Overall Study
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62
|
|
Overall Study
COMPLETED
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62
|
|
Overall Study
NOT COMPLETED
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0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ultrasound Based Acoustic Radiation Force Impulse Imaging
Baseline characteristics by cohort
| Measure |
Ultrasound-based Acoustic Radiation Force Impulse (ARFI)
n=62 Participants
62 children undergoing clinically ordered ultrasound-directed percutaneous core needle liver biopsy for known or suspected (non-neoplastic) liver disease were included in this study. Subjects were between 0-18 years of age.
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|---|---|
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Age, Categorical
<=18 years
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62 Participants
n=99 Participants
|
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Age, Categorical
Between 18 and 65 years
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0 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
|
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Age, Continuous
|
8.0 years
n=99 Participants
|
|
Sex: Female, Male
Female
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29 Participants
n=99 Participants
|
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Sex: Female, Male
Male
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33 Participants
n=99 Participants
|
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Region of Enrollment
United States
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62 participants
n=99 Participants
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PRIMARY outcome
Timeframe: 10 minutesPopulation: 49 pediatric subjects underwent successful (diagnostic) liver ARFI/VTQ) assessment and liver histologic fibrosis scoring. 13 subjects had non-diagnostic ARFI/VTQ exams. 48 pediatric subjects underwent successful (diagnostic) liver ARFI/VTIQ) assessment and liver histologic fibrosis scoring. 14 subjects had non-diagnostic ARFI/VTIQ exams.
Tissue shear wave speed is positively correlated to a material's/tissue's stiffness and can be noninvasively measured by ultrasound. The relationship between liver shear wave speed and liver histologic fibrosis score were assessed using 2 different ultrasound methods. Liver shear wave speed as obtained using 2 different ultrasound methods served as our primary outcome measures. Note, the histologic scoring system (Ishak) ranged from 0 to 6, where 0 = no fibrosis and 6 = cirrhosis.
Outcome measures
| Measure |
Children Undergoing Diagnostic ARFI/VTQ and Fibrosis Scoring
n=49 Participants
We measured correlation between liver shear wave speed as determined by ARFI (VTQ) and liver histologic fibrosis score.
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Children Undergoing Diagnostic ARFI/VTIQ and Fibrosis Scoring
n=48 Participants
We measured correlation between liver shear wave speed as determined by ARFI/VTIQ and liver histologic fibrosis score.
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|---|---|---|
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ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score
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1.69 m/s
Standard Deviation 0.42
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2.01 m/s
Standard Deviation 0.58
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Adverse Events
All Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jonathan Dillman, MD
Cincinnati Children's Hospital Medical Center, Department of Radiology
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place