B-mode Ultrasound Imaging in Detecting Early Liver Cancer

Cirrhosis Clinical Trial

Official title:

Quantitative Ultrasound Spectroscopy to Early HCC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774161
• Other study ID #: IRB-36299
• Secondary ID: NCI-2016-00663GI
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: June 19, 2017

Study information

• Verified date: August 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 19, 2017
• Est. primary completion date: June 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Cirrhosis
• Early Hepatocellular Carcinoma
• Fibrosis
• Stage I Hepatocellular Carcinoma
• Stage II Hepatocellular Carcinoma

Intervention

Other:
• Ultrasound Tomography
Undergo B-mode ultrasound imaging

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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