Trial Outcomes & Findings for Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study (NCT NCT04657523)
NCT ID: NCT04657523
Last Updated: 2026-01-23
Results Overview
For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. To assess the correlation between subject averaged measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record. Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF is assessed independently to evaluate individual biomarker performance. A higher attenuation value indicates worse liver condition, while a lower attenuation value suggests better liver status.
COMPLETED
NA
60 participants
Intra-procedural (1 day)
2026-01-23
Participant Flow
Participant milestones
| Measure |
Investigational Ultrasound Imaging for Liver Fat Quantification
Investigational Liver Fat Quantification Software: All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.
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Overall Study
STARTED
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60
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Overall Study
COMPLETED
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60
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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
Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study
Baseline characteristics by cohort
| Measure |
Investigational Ultrasound Imaging for Liver Fat Quantification
n=60 Participants
Investigational Liver Fat Quantification Software: All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.
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Age, Categorical
<=18 years
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0 Participants
n=270 Participants
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Age, Categorical
Between 18 and 65 years
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51 Participants
n=270 Participants
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Age, Categorical
>=65 years
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9 Participants
n=270 Participants
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Age, Continuous
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53.7 years
STANDARD_DEVIATION 12.9 • n=270 Participants
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Sex: Female, Male
Female
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38 Participants
n=270 Participants
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Sex: Female, Male
Male
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22 Participants
n=270 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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4 Participants
n=270 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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56 Participants
n=270 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=270 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=270 Participants
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Race (NIH/OMB)
Asian
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2 Participants
n=270 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=270 Participants
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Race (NIH/OMB)
Black or African American
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5 Participants
n=270 Participants
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Race (NIH/OMB)
White
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51 Participants
n=270 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=270 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=270 Participants
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Region of Enrollment
United States
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60 participants
n=270 Participants
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PRIMARY outcome
Timeframe: Intra-procedural (1 day)Population: Each enrolled subject underwent up to two ultrasound scans conducted by two different operators, resulting in a total of 119 non missing scans reviewed for this study. The primary outcome measure, the Hepatorenal Index, was calculated based on these scans. The hepatorenal index measurement from each ultrasound scan was reviewed.
For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. The difference between the two operators was calculated at the subject level by averaging multiple measurements. To assess the correlation between measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record. A higher HRI value indicates greater liver fat accumulation, which reflects a worse outcome, while a lower HRI suggests less hepatic fat and a better outcome.
Outcome measures
| Measure |
Investigational Ultrasound Imaging for Liver Fat Quantification
n=119 ultrasounds scans
Investigational Liver Fat Quantification Software: All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.
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|---|---|
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Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements Hepatorenal Index (HRI) of Ultrasound Biomarkers for Liver Fat.
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1.6 Hepatorenal Index
Standard Deviation 0.7
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PRIMARY outcome
Timeframe: Intra-procedural (1 day)Population: Each enrolled subject underwent up to two ultrasound scans conducted by two different operators, resulting in a total of 120 scans reviewed for this study. The primary outcome measure, the Acoustic Attenuation (dB/cm/MHZ), was evaluated based on these scans.
For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. To assess the correlation between subject averaged measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record. Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF is assessed independently to evaluate individual biomarker performance. A higher attenuation value indicates worse liver condition, while a lower attenuation value suggests better liver status.
Outcome measures
| Measure |
Investigational Ultrasound Imaging for Liver Fat Quantification
n=120 Ultrasound scans
Investigational Liver Fat Quantification Software: All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.
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|---|---|
|
Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Acoustic Attenuation (dB/cm/MHZ) Ultrasound Biomarker for Liver Fat.
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1.0 dB/cm/MHZ
Standard Deviation 0.7
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PRIMARY outcome
Timeframe: Intra-procedural (1 day)Population: Each enrolled subject underwent up to two ultrasound scans conducted by two different operators, resulting in a total of 120 scans reviewed for this study. The primary outcome measure, the Tissue Stiffness, was evaluated based on these scans.
For each biomarker per subject, multiple quantitative measurements were acquired on the same day by two different operators. To assess the correlation between subject averaged measurements derived from the investigational LFQ feature and the 'clinical' MRI-PDFF fat fraction obtained from the subject's medical record. This measured the MRI PDFF fat fraction used as the standard to evaluate the Tissue stiffness (kPa) measurements. Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF is assessed independently to evaluate individual biomarker performance.
Outcome measures
| Measure |
Investigational Ultrasound Imaging for Liver Fat Quantification
n=120 Ultrasound scans
Investigational Liver Fat Quantification Software: All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.
|
|---|---|
|
Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Tissue Stiffness (kPa) Ultrasound Biomarker for Liver Fat.
|
5.9 kPa
Standard Deviation 1.8
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SECONDARY outcome
Timeframe: Intra-procedural (1 day)Population: The analysis included 119 ultrasound scans, performed by two different operators, from 60 enrolled participants. One participant scan was excluded due to missing Hepatorenal Index (HRI) data. The hepatorenal index measurement was calculated from each ultrasound scan and the difference between the two operators was reviewed.
To assess the difference in quantitative ultrasound biomarker measurements which acquired from the same subject on the same day by two different operators who have undergone standardized training for LFQ data acquisition. The difference between the two operators was calculated at the subject level by averaging multiple measurements. A higher HRI value indicates greater liver fat accumulation, which reflects a worse outcome, while a lower HRI suggests less hepatic fat and a better outcome.
Outcome measures
| Measure |
Investigational Ultrasound Imaging for Liver Fat Quantification
n=119 ultrasound scans
Investigational Liver Fat Quantification Software: All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.
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|---|---|
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To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker "Hepatorenal Index (HRI)"
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-0.1 Hepatorenal Index
Standard Deviation 0.4
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SECONDARY outcome
Timeframe: Intra-procedural (1 day)Population: To quantify the number of overall subjects with at least one unacceptable image quality
To evaluate the LFQ data acquisition failure rate, the proportion of subjects who have at least one unacceptable image quality due to inadequate acoustic scanning windows, motion artifacts, or other technical limitations
Outcome measures
| Measure |
Investigational Ultrasound Imaging for Liver Fat Quantification
n=60 Participants
Investigational Liver Fat Quantification Software: All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.
|
|---|---|
|
To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker "Hepatorenal Index (HRI)"
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1 Participants
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SECONDARY outcome
Timeframe: Intra-procedural (1 day)Population: 60 participants enrolled were included in the analysis.
To evaluate the LFQ data acquisition failure rate, the proportion of subjects who have at least one unacceptable image quality due to inadequate acoustic scanning windows, motion artifacts, or other technical limitations
Outcome measures
| Measure |
Investigational Ultrasound Imaging for Liver Fat Quantification
n=60 Participants
Investigational Liver Fat Quantification Software: All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.
|
|---|---|
|
To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ)
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0 Participants
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SECONDARY outcome
Timeframe: Intra-procedural (1 day)Population: 60 participants enrolled were included in the analysis.
To evaluate the LFQ data acquisition failure rate, the proportion of subjects who have at least one unacceptable image quality due to inadequate acoustic scanning windows, motion artifacts, or other technical limitations
Outcome measures
| Measure |
Investigational Ultrasound Imaging for Liver Fat Quantification
n=60 Participants
Investigational Liver Fat Quantification Software: All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.
|
|---|---|
|
To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Tissue Stiffness (kPa)
|
1 Participants
|
SECONDARY outcome
Timeframe: Intra-procedural (1 day)Population: The analysis included 120 ultrasound scans, performed by two different operators, from 60 enrolled participants. The Acoustic attenuation (dB/cm/MHZ) calculated from each ultrasound scan and the difference between the two operators was reviewed.
To assess the difference in quantitative ultrasound biomarker measurements which acquired from the same subject on the same day by two different operators who have undergone standardized training for LFQ data acquisition. The difference between the two operators was calculated at the subject level by averaging multiple measurements.
Outcome measures
| Measure |
Investigational Ultrasound Imaging for Liver Fat Quantification
n=120 ultrasound scans
Investigational Liver Fat Quantification Software: All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.
|
|---|---|
|
To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ)
|
0.0 dB/cm/MHZ
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Intra-procedural (1 day)Population: The analysis included 120 ultrasound scans, performed by two different operators, from 60 enrolled participants. The Tissue stiffness (kPa) was calculated from each ultrasound scan and the difference between the two operators was reviewed.
To assess the difference in quantitative ultrasound biomarker measurements which acquired from the same subject on the same day by two different operators who have undergone standardized training for LFQ data acquisition. The difference between the two operators was calculated at the subject level by averaging multiple measurements.
Outcome measures
| Measure |
Investigational Ultrasound Imaging for Liver Fat Quantification
n=120 ultrasound scans
Investigational Liver Fat Quantification Software: All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.
|
|---|---|
|
To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Tissue Stiffness (kPa)
|
0.1 Tissue stiffness (kPa)
Standard Deviation 1.9
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Adverse Events
Investigational Ultrasound Imaging for Liver Fat Quantification
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