Ultrasound-Based Liver Fat Quantification (LFQ) Pilot Study

Не применимо Завершено NCT04657523

Заболевание	Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
Фаза	Не применимо
Спонсор	Philips Clinical & Medical Affairs Global
Статус	Завершено
Участники	60 участн.
Вмешательство	Investigational Liver Fat Quantification Software
Дата начала	30.10.2020
Дата завершения	18.01.2023
Публикация результатов	23.01.2026

Кратко

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 Quantification	1.6 ± 0.7 Hepatorenal Index

Pearson correlation coefficient	0.5749

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 Quantification	1.0 ± 0.7 dB/cm/MHZ

Pearson correlation coefficient	0.6824

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 Quantification	5.9 ± 1.8 kPa

Pearson correlation coefficient	-0.0539

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Все исследования

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