B-mode Ultrasound Imaging in Detecting Early Liver Cancer

Stanford University

Status: Completed

Conditions: Early Hepatocellular Carcinoma; Stage I Hepatocellular Carcinoma; Cirrhosis; Fibrosis; Stage II Hepatocellular Carcinoma

Treatments: Other: Ultrasound Tomography

Study type: Interventional

Funder types: Other

Identifiers

NCT02774161

NCI-2016-00663 (Registry Identifier)

IRB-36299

GIIMG0007 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Diagnostic (B-mode ultrasound imaging)

Experimental group

Description:

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

Treatment:

Other: Ultrasound Tomography