B-mode Ultrasound Imaging in Detecting Early Liver Cancer | NCT02774161

Studies
B-mode Ultrasound Imaging in Detecting Early Liver Cancer

NCT02774161

Sponsor

Stanford University

Status

Completed

Last Update Posted

Aug 3, 2021Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

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

Interventions

Ultrasound Tomography

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2016-00663	Registry Identifier	CTRP (Clinical Trial Reporting Program)
GIIMG0007	Other Identifier	OnCore

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2016Actual

Primary Completion Date

Jun 19, 2017Actual

Completion Date

Jun 19, 2017Actual

First Submitted Date

May 2, 2016

First Submission Date that Met QC Criteria

May 12, 2016

First Posted Date

May 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2021

Last Update Posted Date

Aug 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnostic (B-mode ultrasound imaging)	Experimental	Patients undergo B-mode ultrasound imaging of the liver over 15 minutes.	Other: Ultrasound Tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound Tomography	Other	Undergo B-mode ultrasound imaging	Diagnostic (B-mode ultrasound imaging)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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
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
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Aya Kamaya	Stanford University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University, School of Medicine		Palo Alto	California	94305	United States

Condition Browse Module

MeSH Terms

ID	Term
D005355	Fibrosis
D006528	Carcinoma, Hepatocellular

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D000230	Adenocarcinoma
D002277	Carcinoma

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Browse Branches

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