Raw Ultrasound-Based Artificial Intelligence Technology Data Collection for Patients at Risk of or With Liver Disease

Overview

About this study

The purpose of this study is to collect raw ultrasound data, using an FDA-approved portable ultrasound transducer, from patients with confirmed or suspected liver disease, or a liver graft (transplant). Oncoustics is developing AI-based software which detects and characterizes liver fibrosis, steatosis, inflammation, hepatic decompensation associated with cirrhosis, and a variety of liver lesions including hepatocellular carcinoma.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Alina Allen, M.D., M.S.

Open for enrollment

Contact information:

Jessica Olson

(507) 266-3995

Olson.Jessica3@mayo.edu

More information

Publications

Publications are currently not available