BENITIONSClinical Trial Intelligence

Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study

단계 해당 없음 완료 NCT04657523

대상 질환Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
임상 단계단계 해당 없음
스폰서Philips Clinical & Medical Affairs Global
상태완료
참여자 수60 명
중재(약물)Investigational Liver Fat Quantification Software
시작일2020년 10월 30일
완료일2023년 1월 18일
결과 공개일2026년 1월 23일

요약

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.

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) · Hepatorenal Index

Investigational Ultrasound Imaging for Liver Fat Quantification1.6 ± 0.7 Hepatorenal Index
Pearson correlation coefficient0.5749

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) · dB/cm/MHZ

Investigational Ultrasound Imaging for Liver Fat Quantification1.0 ± 0.7 dB/cm/MHZ
Pearson correlation coefficient0.6824

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) · kPa

Investigational Ultrasound Imaging for Liver Fat Quantification5.9 ± 1.8 kPa
Pearson correlation coefficient-0.0539

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