B-mode Ultrasound Imaging in Detecting Early Liver Cancer

Study Overview
=================
Brief Summary
-----------------
This pilot trial studies how well B-mode ultrasound imaging works in detecting liver cancer that is early in its growth and may not have spread to other parts of the body. Diagnostic procedures, such as B-mode ultrasound imaging, may help find and diagnose liver cancer and find out how far the disease has spread.

Detailed Description
-----------------
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.

Official Title
-----------------
Quantitative Ultrasound Spectroscopy to Early HCC

Conditions
-----------------
Cirrhosis, Early Hepatocellular Carcinoma, Fibrosis, Stage I Hepatocellular Carcinoma, Stage II Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Other: Ultrasound Tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For Healthy Volunteers Patients over 18 years of age. 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 Patients over 18 years of age. 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 Patients should not be taking other Investigational Agents. Concomitant medications for treatment of the target lesion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (B-mode ultrasound imaging)<br>Patients undergo B-mode ultrasound imaging of the liver over 15 minutes. | Other: Ultrasound Tomography<br>* Undergo B-mode ultrasound imaging<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mid-band fit | The Mid-band fit is related to the intensity of the returned ultrasound signal at different frequencies has been shown to change with tissue morphology. | Up to 16 months | 
| Spectral intercept | Spectral intercept (SI) is mostly related to the number scatterers and their density in the tissue. Changes in the SI have been demonstrated to occur due to different pathologies and result from treatments that change the structure of the tissue being imaged. | Up to 16 months | 
| Spectral slope | Summarized as the maximum and/or average value over the lesion of interest (using a region of interest selection) and the liver image as a whole. | Up to 16 months |