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

Kidney Tumor Clinical Trial

Official title:

US Elastography for Characterizing Focal Lesions in the Liver and Kidney

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01908166
• Other study ID #: VAR0099
• Secondary ID: NCI-2013-01353P3
• Status: Completed
• Phase: N/A
• First received: July 23, 2013
• Last updated: June 6, 2017
• Start date: January 2014
• Est. completion date: November 1, 2016

Study information

• Verified date: June 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 1, 2016
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adult Primary Liver Cancer
• Kidney Neoplasms
• Kidney Tumor
• Liver Neoplasms

Intervention

Procedure:
• ultrasound elasticity imaging
Undergo ultrasound elastography

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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