Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

B-mode Ultrasound Imaging in Detecting Early Liver Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02774161
Recruitment Status : Suspended (logistics)
First Posted : May 17, 2016
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Aya Kamaya, Stanford University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Cirrhosis Early Hepatocellular Carcinoma Fibrosis Stage I Hepatocellular Carcinoma Stage II Hepatocellular Carcinoma Other: Ultrasound Tomography Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Quantitative Ultrasound Spectroscopy to Early HCC
Study Start Date : May 2016
Estimated Primary Completion Date : June 19, 2020
Estimated Study Completion Date : June 19, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Diagnostic (B-mode ultrasound imaging)
Patients undergo B-mode ultrasound imaging of the liver over 15 minutes.
 Other: Ultrasound Tomography
Undergo B-mode ultrasound imaging


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mid-band fit [ Time Frame: 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.

  2. Spectral intercept [ Time Frame: 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.

  3. Spectral slope [ Time Frame: 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774161


Locations
Layout table for location information
United States, California
Stanford University, School of Medicine
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Layout table for investigator information
Principal Investigator: Aya Kamaya Stanford University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Aya Kamaya, Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT02774161    
Other Study ID Numbers: GIIMG0007
NCI-2016-00663 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
IRB-36299 ( Other Identifier: Stanford IRB )
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
 Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases