Clinical Trials

Inclusion Criteria:

• Patient (age 18 - 75) with:
  • suspected or confirmed fibrosis/cirrhosis, steatosis, inflammation, and/or incidental liver lesion(s); or
  • recipient of a liver graft, with a minimum time of 1 year since transplantation.
• Ability to understand and willingness to sign the written informed consent document.
• Patient has undergone one or more of the following procedures within 1 month of the Oncoustics scan (study procedure) or is scheduled to receive one of more of these procedures within 1 month of the Oncoustics scan: FibroScan®, VelacurTM, MRE, SWE, SWS, MRI-PDFF; Or patient has had a liver biopsy within 6 months (but greater than 1 month) of the Oncoustics scan and not received any “treatment” for their condition between the time of the biopsy and the scan, or is scheduled for liver biopsy in the 6 months (but greater than 1 month) following the scan.
• (For patients with a known tumor): any patient can be recruited if the patient received or will receive an ultrasound surveillance (i.e., presence of nodule), early assessment (diagnosis with US Li-Rads) and/or MRI/CT definitive diagnosis (diagnosis + Li-Rads) which confirms diagnosis as HCC, Hemangioma, Adenoma, FNH, Cysts, Regenerative nodule, Fat sparing, Focal fat etc., others within 3 months of the Oncoustics Scan.

Exclusion Criteria:

• Age < 18 or ≥ 75.
• If female and of child-bearing potential: pregnant, suspected or planning to become pregnant or breast-feeding.
• Inability to consent.
• Acute abdominal conditions, local skin diseases and severe musculoskeletal disorders that would not allow comfortable ultrasound assessment of the liver.
• Individuals may not receive any sort of medical treatment or intervention between the time of the OnX scan and the respective primary clinical standard assessment.
• No individuals with implanted electrical devices.
• No biopsy within 1-month prior to OnX scan.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/10/23. Questions regarding updates should be directed to the study team contact.