Trial Outcomes & Findings for Noninvasive Biomarkers of Metabolic Liver Disease 1.1 (NCT NCT04828551)
NCT ID: NCT04828551
Last Updated: 2023-07-11
Results Overview
The same research subject undergoes multiple shear wave elastography measurements (measured in m/s) on multiple ultrasound imaging devices and transient elastography at two visits (baseline + up to 7 days) with different operators. Elastographic measurements are recorded. The median shear wave velocity value (in m/s) is computed for each ultrasound imaging device and is displayed by the transient elastography device. The ultrasound machine measurements are pooled and the pooled different day-different operator reproducibility coefficient for the group of ultrasound machines is computed. The reproducibility coefficient for transient elastography is computed separately. The pooled different-day, different-operator reproducibility coefficient of ultrasound measurements of shear wave speed, is reported in the outcome measure data table section.
COMPLETED
NA
40 participants
(2 visits, baseline + up to 7 days). Outcome measure will be assessed after pooling measurements from all study subjects.
2023-07-11
Participant Flow
Participant milestones
| Measure |
MGH and UCSD Study Subjects
This study will enroll patients with suspected or confirmed diagnosis of NAFLD. Based on protocol-specified FIB-4 values, about one-third are expected to have low, one-third to have intermediate, and one-third to have high likelihood of advanced fibrosis.
Sex: 50:50 - Note- no stratification will be done based on sex Age: ≥ 18 yrs Demographic group: Patients with a high probability of NAFLD based on the eligibility criteria General health status: Patients with suspected or confirmed diagnosis of NAFLD Geographic location: Boston, MA (greater metropolitan areas) and San Diego, CA (greater metropolitan areas)
Ultrasound based shear wave speed and fat quantification methods: Ultrasound based imaging parameters will be collected from all patients in two visits. These will include but may not be limited to SWE results, Quantitative ultrasound parameters,where available,including Attenuation Coefficient, Backscatter Coefficient, Shear Wave Dispersion, Speed of Sound, Ultrasound derived fat fraction Conventional Bmode (gray-scale) and Doppler ultrasound images,including An image of the liver and right kidney on the same image for hepatorenal index calculation Right liver lobe for skin to liver capsule distance calculation Portal vein Doppler for portal vein pulsatility index measurement VCTE and Controlled Attenuation Parameter measurements with the Fibroscan system
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|---|---|
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Overall Study
STARTED
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40
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Overall Study
COMPLETED
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40
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Noninvasive Biomarkers of Metabolic Liver Disease 1.1
Baseline characteristics by cohort
| Measure |
MGH and UCSD Study Subjects
n=40 Participants
NAFLD patients with ultrasound elastography and fat quantification measurements
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
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Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=5 Participants
|
|
Age, Continuous
|
60.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
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Region of Enrollment
United States
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40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: (2 visits, baseline + up to 7 days). Outcome measure will be assessed after pooling measurements from all study subjects.The same research subject undergoes multiple shear wave elastography measurements (measured in m/s) on multiple ultrasound imaging devices and transient elastography at two visits (baseline + up to 7 days) with different operators. Elastographic measurements are recorded. The median shear wave velocity value (in m/s) is computed for each ultrasound imaging device and is displayed by the transient elastography device. The ultrasound machine measurements are pooled and the pooled different day-different operator reproducibility coefficient for the group of ultrasound machines is computed. The reproducibility coefficient for transient elastography is computed separately. The pooled different-day, different-operator reproducibility coefficient of ultrasound measurements of shear wave speed, is reported in the outcome measure data table section.
Outcome measures
| Measure |
MGH and UCSD Study Subjects
n=3600 SWS measurements on ultrasound images
Ultrasound based shear wave speed (SWS) and transient elastography based SWS measurements were collected from MGH and UCSD study subjects. SWS and transient elastography measurements are obtained in m/s unit.
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|---|---|
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Evaluation of Pooled Different-day, Different-operator Reproducibility of Shear Wave Speed Measurements
|
30.7 Reproducibility coefficient (in %)
|
PRIMARY outcome
Timeframe: (2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling all measurements from all study subjects.The same research subject undergoes multiple shear wave elastography measurements (measured in m/s) on multiple ultrasound imaging devices and transient elastography at two visits (baseline + up to 7 days) with different operators. Elastographic measurements are recorded. The median shear wave velocity value (in m/s) is computed for each ultrasound imaging device and is displayed by the transient elastography device. The ultrasound machine measurements are pooled and the pooled different day-different operator reproducibility coefficient for the group of ultrasound machines is computed. The reproducibility coefficient for transient elastography is computed separately. The pooled different-day, different-operator reproducibility coefficient of transient elastography measurements (in m/s unit), is reported in the outcome measure data table section.
Outcome measures
| Measure |
MGH and UCSD Study Subjects
n=1170 SWS measurements on ultrasound images
Ultrasound based shear wave speed (SWS) and transient elastography based SWS measurements were collected from MGH and UCSD study subjects. SWS and transient elastography measurements are obtained in m/s unit.
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|---|---|
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Different-day, Different-operator Reproducibility Coefficient of Transient Elastography Based Shear Wave Speed Measurements
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35.6 Reproducibility coefficient (in %)
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SECONDARY outcome
Timeframe: (2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling measurements from all study subjects.The same research subject undergoes multiple SWE measurements (in m/s) on multiple devices and transient elastography (TE) at two visits (in 7 days) with different operators. For this outcome measure, the same-day same-operator repeatability is estimated on repeated measurements performed on the same device by the same operator at the same visit. For example, the following structure is followed for a subject; Day1 (Device A, Device B, Device C, TE, Repeated Device A, Repeated Device B), Day2 (Device A, Device B, Device C, TE, Repeated Device C, Repeated TE). The median SWS value (in m/s) is computed for each ultrasound device and is displayed by the TE device. The pooled same-day, same-operator repeatability coefficient of ultrasound measurements of SWS, is reported in the outcome measure data table section.
Outcome measures
| Measure |
MGH and UCSD Study Subjects
n=3600 SWS measurements on ultrasound images
Ultrasound based shear wave speed (SWS) and transient elastography based SWS measurements were collected from MGH and UCSD study subjects. SWS and transient elastography measurements are obtained in m/s unit.
|
|---|---|
|
Evaluation of Pooled Same-day, Same-operator Repeatability of Shear Wave Speed (SWS)
|
21 Repeatability coefficient (in %)
|
SECONDARY outcome
Timeframe: (2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling all measurements from all study subjects.The same research subject undergoes multiple shear wave elastography measurements (measured in m/s) on multiple ultrasound imaging devices and transient elastography at two visits (baseline + up to 7 days) with different operators. The median shear wave velocity value (in m/s) is computed for each ultrasound imaging device and is displayed by the transient elastography device. The reproducibility coefficient of measurements obtained across different ultrasound devices on the same day by the same operator is computed. For example, the following structure is followed for a study subject; Day1 (Device A, Device B, Device C, Transient elastography, Repeated Device A, Repeated Device B), Day2 (Device A, Device B, Device C, Transient elastography, Repeated Device C, Repeated transient elastography).The pooled different-scanner, same-day reproducibility coefficient of ultrasound measurements of SWS, is reported in the outcome measure data table section.
Outcome measures
| Measure |
MGH and UCSD Study Subjects
n=3600 SWS measurements on ultrasound images
Ultrasound based shear wave speed (SWS) and transient elastography based SWS measurements were collected from MGH and UCSD study subjects. SWS and transient elastography measurements are obtained in m/s unit.
|
|---|---|
|
Evaluation of Pooled Different-scanner, Same-day Reproducibility of Shear Wave Elastography.
|
52.7 Reproducibility coefficient (in %)
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SECONDARY outcome
Timeframe: (2 visits, baseline + up to 7days). Outcome measure will be assessed after pooling all measurements from all study subjects.Same day same operator repeat median TE measures expressed in m/s are compared and the repeatability is estimated. For example, the following structure is followed for a study subject; Day1 (Device A, Device B, Device C, Transient elastography, Repeated Device A, Repeated Device B), Day2 (Device A, Device B, Device C, Transient elastography, Repeated Device C, Repeated transient elastography), which allows estimation of same-day same operator repeatability.
Outcome measures
| Measure |
MGH and UCSD Study Subjects
n=1170 SWS measurements on ultrasound images
Ultrasound based shear wave speed (SWS) and transient elastography based SWS measurements were collected from MGH and UCSD study subjects. SWS and transient elastography measurements are obtained in m/s unit.
|
|---|---|
|
Evaluation of Same-day, Same-operator Repeatability of Transient Elastography
|
19.6 Repeatability coefficient (in %)
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Adverse Events
MGH and UCSD Study Subjects
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place