Thermoacoustic Method for Estimating Liver Fat Fraction

The study will perform thermoacoustic fat measurements for up to 80 participants, over the span of the study. MRI-PDFF sequences will be acquired for participants in the study to establish a true measure of liver fat content, per the MRI gold standard. Determine the correlation between FLIP CID system Fat fraction results and the MRI-PDFF. Determine the accuracy between the fat measures obtained by the FLIP CID system participants who received a quantitative MRI. The following additional parameters will be evaluated endpoints: Sensitivity, Specificity ,Positive and negative predictive value (PPV, NPV) and The area under the ROC curve for the detection of liver fat abnormalities

Inclusion criteria

• Study participants are 18 or older.
• Able to understand, read, and provide written informed consent in English.
• Able to tolerate both ultrasound and MRI examinations.
• Able to lie flat, or on their side, for 20 minutes and pause breathing for up to 10 seconds.

Exclusion criteria

• Metal or electronic implants, including, but not limited to: pacemakers, metal clips, drug delivery pumps, hip implants, and neural stimulation devices, contraindicates for MRI.
• Known pregnancy the day of consent or becoming pregnant during study participation based on start date of last menstrual period).
• Liver diseases other than MASLD/MASH/fibrosis including, but not limited to:
• Cirrhosis
• Hepatocellular carcinoma
• Ascites
• Patients with broken, or injured skin, in the right upper abdominal quadrant.
• Body habitus, or anatomical variation, where the liver capsule is not accessible with ultrasound through the patient's right intercostal imaging window used in conventional ultrasound liver imaging.
• BMI greater than 50 kg/m2
• Patients with subcutaneous fat at measurement location less than or equal to 6mm.
• Patients with a missing liver lobe.
• Patients with peri-hepatic fat in the measurement location.
• Patients with focal liver lesions or anatomical structures in the measurement location, as detected by ultrasound.