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B-mode Ultrasound Imaging in Detecting Early Liver Cancer

Primary Purpose

Cirrhosis, Early Hepatocellular Carcinoma, Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ultrasound Tomography
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cirrhosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (B-mode ultrasound imaging)

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
May 2, 2016
Last Updated
August 2, 2021
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02774161
Brief Title
B-mode Ultrasound Imaging in Detecting Early Liver Cancer
Official Title
Quantitative Ultrasound Spectroscopy to Early HCC
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
June 19, 2017 (Actual)
Study Completion Date
June 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis, Early Hepatocellular Carcinoma, Fibrosis, Stage I Hepatocellular Carcinoma, Stage II Hepatocellular Carcinoma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (B-mode ultrasound imaging)
Arm Type
Experimental
Arm Description
Patients undergo B-mode ultrasound imaging of the liver over 15 minutes.
Intervention Type
Other
Intervention Name(s)
Ultrasound Tomography
Intervention Description
Undergo B-mode ultrasound imaging
Primary Outcome Measure Information:
Title
Mid-band fit
Description
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.
Time Frame
Up to 16 months
Title
Spectral intercept
Description
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.
Time Frame
Up to 16 months
Title
Spectral slope
Description
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.
Time Frame
Up to 16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aya Kamaya
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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B-mode Ultrasound Imaging in Detecting Early Liver Cancer

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