Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
Conditions
Keywords
Liver Fat Quantification, Ultrasound, Liver Disease, Digestive System Disease
Brief summary
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 two investigational abdominal ultrasound examinations using the Philips EPIQ Ultrasound System and one MRI PDFF examination according to the clinical standard of care.
Interventions
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.
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must be at least 18 years old and able to provide written informed consent * Must attest to absent or minimal alcohol consumption (i.e. \< 2 alcoholic beverages per day for women and \< 3 alcoholic beverages per day for men, where an alcoholic beverage is defined as 12 oz. of regular beer, 5 oz. of wine, or 1.5 oz. of distilled spirits). * Must be eligible for a standard abdominal ultrasound examination and standard non-contrast MRI examination. * At least one of the following criteria must also be met: Overweight or obese (BMI ≥ 25); Diagnosed with Type 2 diabetes; Diagnosed with hypercholesterolemia; Diagnosed with or clinically suspected of having NAFLD/NASH
Exclusion criteria
* Evidence of moderate/heavy/binge alcohol consumption exceeding the thresholds above * Evidence of hepatotoxicity * History of chronic liver disease (e.g., viral, cholestatic, or autoimmune). * Use of drugs associated with hepatic steatosis * Subjects anticipated or planned to undergo any diagnostic or therapeutic intervention during enrollment period that, at discretion of the Investigator, may affect liver fat content * Hepatic lesions that cannot be excluded from the imaging field during ultrasound LFQ data acquisition * History of previous liver surgery or hepatic implants that, at the discretion of the Investigator, may adversely impact ultrasound or MRI image quality or the subject's eligibility to undergo ultrasound or MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements Hepatorenal Index (HRI) of Ultrasound Biomarkers for Liver Fat. | Intra-procedural (1 day) | 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. |
| Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Acoustic Attenuation (dB/cm/MHZ) Ultrasound Biomarker for Liver Fat. | Intra-procedural (1 day) | 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. |
| Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Tissue Stiffness (kPa) Ultrasound Biomarker for Liver Fat. | Intra-procedural (1 day) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker "Hepatorenal Index (HRI)" | Intra-procedural (1 day) | 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. |
| To Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker "Hepatorenal Index (HRI)" | Intra-procedural (1 day) | 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 Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ) | Intra-procedural (1 day) | 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 Evaluate the LFQ Data Acquisition Failure Rate for Investigating Biomarker Tissue Stiffness (kPa) | Intra-procedural (1 day) | 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 Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Acoustic Attenuation (dB/cm/MHZ) | Intra-procedural (1 day) | 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. |
| To Evaluate the Same-day Inter-operator Variability for Investigating Biomarker Tissue Stiffness (kPa) | Intra-procedural (1 day) | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnthony E. Samir, MD
Massachusetts General Hospital
PRINCIPAL_INVESTIGATORStephan Anderson, MD
Boston Medical Center
PRINCIPAL_INVESTIGATORRichard G Barr, MD, PhD
Radiology Consultants, Inc
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 9 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants |
| Age, Continuous | 53.7 years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 51 Participants |
| Region of Enrollment United States | 60 participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
None listed