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 one investigational abdominal ultrasound examination 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
5 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Subjects at least 5 years old up through and including 21 years old who are able to provide informed consent to participate or have a legal representative/parent/legal guardian who is able to provide informed consent for the subject to participate. * Subjects must be eligible for a standard abdominal ultrasound examination and standard non-contrast MRI examination. In addition, at least one of the following criteria must also be met: * Overweight or obese (BMI-for-age ≥ 85th percentile). * Diagnosed with Type 2 diabetes per standard clinical guidelines. * Diagnosed with hypercholesterolemia per standard clinical guidelines. * Diagnosed with or clinically suspected of having NAFLD/NASH based on previous medical record, medical imaging, liver biopsy, and/or laboratory testing.
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: * Amiodarone * Methotrexate * Nucleoside reverse transcriptase inhibitors (didanosine, stavudine) * Valproic acid * Dexamethasone * Tamoxifen * 5-FU-based adjuvant chemotherapy * Apo-B inhibitors (mipomersen, lomitapide) * Tetracycline exceeding 2 g/day * Acetylsalicylic acid exceeding 150 mg/kg
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of the Liver Fat Percentage Reported From MRI-PDFF With Measurements of Hepatorenal Index (HRI) 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. 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 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. 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. |
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 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 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 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_INVESTIGATORSmita S Bailey, MD
Phoenix Children's Hospital
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 11.8 years STANDARD_DEVIATION 3.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Height | 151.3 cm STANDARD_DEVIATION 16.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 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 | 10 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 15 Participants |
| Weight | 67.9 kg STANDARD_DEVIATION 126.5 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
None listed