B-mode Ultrasound Imaging in Detecting Early Liver Cancer

PRIMARY OBJECTIVES:

I. To investigate the use of quantitative ultrasound spectroscopy to detect early
hepatocellular carcinoma (HCC) as an inexpensive and widely available quantitative (i.e.
robust) method to confirm disease in developing countries.

OUTLINE:

Patients undergo B-mode ultrasound imaging of the liver over 15 minutes.

Inclusion Criteria:

For Healthy Volunteers

1. Patients over 18 years of age.

2. Must have no known medical problems and have had a full medical exam within 6 months
of the study. If healthy volunteers have not had a full medical exam within 6 months
of the study, one of the ultrasound physicians will conduct the medical exam prior to
any study procedures.

For HCC patients

1. Patients over 18 years of age.

2. Patient with confirmed diagnosis of HCC, and untreated or Patients with Suspected HCC
(Suspected HCC nodules should preferably be smaller than 3 cm and preferably within 6
cm in depth of the transducer head to minimize attenuation) and untreated or Patients
at a higher risk of HCC undergoing a screening program by Ultrasound.

Exclusion Criteria:

For Healthy volunteers

1. Patients who are not likely to comply with the protocol requirements.

For HCC patients

1. Patients should not be taking other Investigational Agents.

2. Concomitant medications for treatment of the target lesion.