Ultrasound Elastography in Diagnosing Patients With Kidne... | NCT01908166

Studies
Ultrasound Elastography in Diagnosing Patients With Kidney or Liver Solid Focal Lesions

NCT01908166

Sponsor

Stanford University

Status

Completed

Last Update Posted

Jun 8, 2017Actual

Enrollment

61Actual

Phase

Not Applicable

Conditions

Adult Primary Liver Cancer
Kidney Tumor

Interventions

ultrasound elasticity imaging

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-2013-01353	Registry Identifier	CTRP (Clinical Trial Reporting Program)
P30CA124435	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2017

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

Jan 2014

Primary Completion Date

Nov 1, 2016Actual

Completion Date

Nov 1, 2016Actual

First Submitted Date

Jul 23, 2013

First Submission Date that Met QC Criteria

Jul 23, 2013

First Posted Date

Jul 25, 2013Estimated

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

Jun 6, 2017

Last Update Posted Date

Jun 8, 2017Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

Brief Summary

This clinical trial studies ultrasound elastography in diagnosing patients with kidney or liver solid focal lesions. New diagnostic procedures, such as ultrasound elastography, may be a less invasive way to check for kidney or liver solid focal lesions.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine the utility of ultrasound elastography in correlation with kidney or liver biopsy or magnetic resonance imaging (MRI) or computed tomography (CT) results.

OUTLINE:

Patients undergo ultrasound elastography.

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

61Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diagnostic (ultrasound elastography)	Experimental	Patients undergo ultrasound elastography.	Procedure: ultrasound elasticity imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ultrasound elasticity imaging	Procedure	Undergo ultrasound elastography	Diagnostic (ultrasound elastography)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Strain ratio for all lesions measured by comparing the lesion to the adjacent normal tissue	Suspicious liver and kidney lesions will be analyzed separately on a per-lesion basis. Within each population, the strain ratio of cases and controls will be compared using the Wilcoxon rank sum test, and the analysis will be illustrated using the non-parametric receiver operating characteristic (ROC).	Up to 36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

There are no restrictions on life expectancy
Eastern Cooperative Oncology Group (ECOG) or Karnofsky performance status will not be employed
Patients of any ethnic background
Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

Patients should not be taking other investigational agents
No requirements due to co-morbid disease or intercurrent illness, as needed
No restrictions on allergic reactions as no imaging agent will be used
Concomitant medications for treatment of the target lesion
Pregnant or nursing patients will be excluded from the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juergen Willmann	Stanford University Hospitals and Clinics	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D006528	Carcinoma, Hepatocellular
D002292	Carcinoma, Renal Cell

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided