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This clinical study will involve performing a series of medical imaging procedures of the abdomen using both ultrasound and MRI modalities in subjects at risk for or already diagnosed with Nonalcoholic Fatty Liver Disease (NAFLD). The primary objective of this clinical study is to evaluate the clinical feasibility of an investigational ultrasound technique for quantifying liver fat by comparing specific ultrasound-derived biomarkers with the liver fat percentage obtained from MRI Proton Density Fat Fraction (MRI-PDFF) measurements. All subjects enrolled in this study will undergo one investigational abdominal ultrasound examination using the Philips EPIQ Ultrasound System and one MRI PDFF examination according to the clinical standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Ultrasound Imaging for Liver Fat Quantification | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Liver Fat Quantification Software | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Hepatorenal Index (HRI) Ultrasound Biomarker for Liver Fat. | 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. | Intra-procedural (1 day) |
| Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Acoustic Attenuation (dB/cm/MHZ) Ultrasound Biomarker for Liver Fat. | 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. | Intra-procedural (1 day) |
| Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Tissue Stiffness (kPa) Ultrasound Biomarkers for Liver Fat. | 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. Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF will be assessed independently to evaluate individual biomarker performance. |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker "Hepatorenal Index (HRI)" | 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. |
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Inclusion Criteria:
In addition, at least one of the following criteria must also be met:
Exclusion Criteria:
History of moderate/heavy/binge alcohol consumption exceeding NIAAA guidelines.
Evidence of hepatotoxicity or cirrhosis in the clinical judgment of the investigator.
History of chronic liver disease other than NAFLD (e.g., viral, cholestatic, or autoimmune).
Use of drugs associated with hepatic steatosis:
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| Name | Affiliation | Role |
|---|---|---|
| Smita S Bailey, MD | Phoenix Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Hepatorenal Index (HRI) Ultrasound Biomarker for Liver Fat. | 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. | Each enrolled subject underwent up to two ultrasound scans conducted by two different operators, resulting in a total of 60 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. | Posted | Mean | Standard Deviation | Hepatorenal Index | Intra-procedural (1 day) | Ultrasound scans | Ultrasound scans |
|
Up to 8 weeks from enrollment to completion of all study-related procedures
No significant foreseeable safety events are associated with this study. No significant ADEs are anticipated because the study procedure is limited to noninvasive diagnostic ultrasound imaging using the investigational LFQ software. The Philips EPIQ Ultrasound System with investigational LFQ software and probes comply with harmonized safety standards governing all diagnostic ultrasound imaging devices and pose no additional risk beyond that associated with any other ultrasound imaging procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rob Johnson; Clinical Study Manager | Philips Ultrasound LLC | 4252757276 | rob.johnson_1@philips.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 6, 2020 | Aug 30, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
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|
| Intra-procedural (1 day) |
| Intra-procedural (1 day) |
| To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker "Hepatorenal Index (HRI)" | 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 | Intra-procedural (1 day) |
| To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ) | 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. | Intra-procedural (1 day) |
| To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Tissue Stiffness (kPa) | 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. | Intra-procedural (1 day) |
| To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Tissue Stiffness (kPa) | 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 | Intra-procedural (1 day) |
| To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ) | 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 | Intra-procedural (1 day) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Title |
|---|
| Description |
|---|
| OG000 | Hepatorenal Index: 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. |
|
|
|
| Primary | Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Acoustic Attenuation (dB/cm/MHZ) Ultrasound Biomarker for Liver Fat. | 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. | Each enrolled subject underwent up to two ultrasound scans conducted by two different operators, resulting in a total of 60 scans reviewed for this study. The primary outcome measure, the Acoustic Attenuation (dB/cm/MHZ), was evaluated based on these scans. The acoustic attenuation from each ultrasound was reviewed. | Posted | Mean | Standard Deviation | dB/CM/MHz | Intra-procedural (1 day) | ultrasound scans | ultrasound scans |
|
|
|
|
| Primary | Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Tissue Stiffness (kPa) Ultrasound Biomarkers for Liver Fat. | 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. Correlation of each ultrasound biomarker with the liver fat percentage reported from MRI-PDFF will be assessed independently to evaluate individual biomarker performance. | Each enrolled subject underwent up to two ultrasound scans conducted by two different operators, resulting in a total of 60 scans reviewed for this study. Two scans were not usable and were excluded from the analysis. So, a total of 58 scans were included for this analysis. | Posted | Mean | Standard Deviation | kPa | Intra-procedural (1 day) | Ultrasound scans | Ultrasound scans |
|
|
|
|
| Secondary | To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker "Hepatorenal Index (HRI)" | 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. | The analysis included 60 ultrasound scans, performed by two different operators, from 30 enrolled participants. The hepatorenal index measurement was calculated from each ultrasound scan and the difference between the two operators was reviewed. | Posted | Mean | Standard Deviation | Hepatorenal Index | Intra-procedural (1 day) | Ultrasound scans | Ultrasound scans |
|
|
|
|
| Secondary | To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker "Hepatorenal Index (HRI)" | 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 | To quantify the number of overall subjects with at least one unacceptable image quality | Posted | Count of Participants | Participants | Intra-procedural (1 day) |
|
|
|
|
| Secondary | To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ) | 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. | The analysis included 60 ultrasound scans, performed by two different operators, from 30 enrolled participants. The acoustic attenuation (dB/cm/MHZ) measurement was calculated from each ultrasound scan and the difference between the two operators was reviewed. | Posted | Mean | Standard Deviation | dB/cm/MHZ | Intra-procedural (1 day) | ultrasound scans | ultrasound scans |
|
|
|
|
| Secondary | To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Tissue Stiffness (kPa) | 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. | The analysis included 58 ultrasound scans, performed by two different operators, from 29 enrolled participants. The Tissue stiffness (kPa) measurement was calculated from each ultrasound scan and the difference between the two operators was reviewed. | Posted | Mean | Standard Deviation | Tissue stiffness (kPa) | Intra-procedural (1 day) | ultrasound scans | ultrasound scans |
|
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| Secondary | To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Tissue Stiffness (kPa) | 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 | 30 participants enrolled were included in the analysis. | Posted | Count of Participants | Participants | Intra-procedural (1 day) |
|
|
|
|
| Secondary | To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ) | 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 | 30 participants enrolled were included in the analysis. | Posted | Count of Participants | Participants | Intra-procedural (1 day) |
|
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|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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To assess the correlation between quantitative ultrasound biomarker "Acoustic attenuation " derived from the investigational LFQ feature and the clinical MRI-PDFF fat fraction obtained from the subject's medical record. |
| Pearson correlation coefficient |
| 0.1770 |
| 2-Sided |
| Other |
Pearson correlation coefficient was calculated based on the subject averages of multiple measurements. |
| To assess the correlation between quantitative ultrasound biomarker "Acoustic attenuation " derived from the investigational LFQ feature and the clinical MRI-PDFF fat fraction obtained from the subject's medical record. | Correlation estimated from a mixed model | 0.1756 | 2-Sided | Other | To account for within subject variance in repeated measures by two different operators, a method with MIXED model for repeated measurements was used to estimate the correlation between two techniques with repeated measures. An unstructured covariance matrix was used. |
To assess the correlation between quantitative ultrasound biomarker "Tissue stiffness" derived from the investigational LFQ feature and the clinical MRI-PDFF fat fraction obtained from the subject's medical record. |
| Pearson correlation coefficient |
| 0.0902 |
| 2-Sided |
| Other |
Pearson correlation coefficient was calculated based on the subject averages of multiple measurements. |
| To assess the correlation between quantitative ultrasound biomarker "Tissue stiffness" derived from the investigational LFQ feature and the clinical MRI-PDFF fat fraction obtained from the subject's medical record. | Correlation estimated from a mixed model | 0.0841 | 2-Sided | Other | To account for within subject variance in repeated measures by two different operators, a method with MIXED model for repeated measurements was used to estimate the correlation between two techniques with repeated measures. An unstructured covariance matrix was used. |