B-mode Ultrasound Imaging in Detecting Early Liver Cancer

Not Applicable

Completed

• Conditions: Stage I Hepatocellular Carcinoma; Cirrhosis; Fibrosis; Stage II Hepatocellular Carcinoma; Early Hepatocellular Carcinoma
• Interventions: Other: Ultrasound Tomography

• Registration Number: NCT02774161
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-02
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-17
• Primary Completion: 2017-06-19
• Study Completion: 2017-06-19
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-02
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (B-mode ultrasound imaging)	Ultrasound Tomography	Patients undergo B-mode ultrasound imaging of the liver over 15 minutes.

Primary Outcome Measures

Name	Time	Method
Spectral slope	Up to 16 months	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.
Mid-band fit	Up to 16 months	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.
Spectral intercept	Up to 16 months	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.

Trial Locations

Locations (1)

Stanford University, School of Medicine; 🇺🇸 Palo Alto, California, United States