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

Not Applicable

Completed

• Conditions: Kidney Tumor; Adult Primary Liver Cancer
• Interventions: Procedure: ultrasound elasticity imaging

• Registration Number: NCT01908166
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2013-07-23
• Study First Submitted QC: 2013-07-23
• Study First Posted: 2013-07-25
• Study Start: 2014-01
• Primary Completion: 2016-11-01
• Study Completion: 2016-11-01
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (ultrasound elastography)	ultrasound elasticity imaging	Patients undergo ultrasound elastography.

Primary Outcome Measures

Name	Time	Method
Strain ratio for all lesions measured by comparing the lesion to the adjacent normal tissue	Up to 36 months	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).

Trial Locations

Locations (1)

Stanford University, School of Medicine; 🇺🇸 Stanford, California, United States