Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With Cirrhosis

Inclusion Criteria:

   - Capable of making informed decisions regarding his/her treatment

   - Have known cirrhosis or other risk factors for HCC, based on American Association for
   the Study of Liver Diseases (AASLD) and European Association for the Study of the
   Liver (EASL) guidelines (applicable in each site jurisdictions)

   - Patients with untreated focal liver observations on liver ultrasound or multiphase
   contrast-enhanced CT or MRI performed as part of clinical standard of care within 4
   weeks before patient enrollment.

OR

• Patients with untreated focal liver observations scheduled for follow-up multiphase
contrast-enhanced CT or MRI, biopsy or surgical excision as part of clinical standard of
care. CEUS should be performed within 4 weeks before or after follow-up imaging or within 4
weeks before biopsy or surgical excision.

Exclusion Criteria:

   - Patients who are pregnant or lactating

   - Patients with focal liver observations less than 5 mm or greater than 5 cm in size

   - Patients with contraindications to CEUS

   - Patients with contraindications to both CT and MRI

   - Patients who are medically unstable, terminally ill, or whose clinical course is
   unpredictable

   - Liver nodule previously treated with trans-arterial or thermal ablation

   - Patients who have received an investigational drug in the 30 days before CEUS, or will
   receive one within 72 hour after their CEUS exam