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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01908166
Recruitment Status : Completed
First Posted : July 25, 2013
Last Update Posted : June 8, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Juergen Willmann, Stanford University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adult Primary Liver Cancer Kidney Tumor Procedure: ultrasound elasticity imaging Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: US Elastography for Characterizing Focal Lesions in the Liver and Kidney
Study Start Date : January 2014
Actual Primary Completion Date : November 1, 2016
Actual Study Completion Date : November 1, 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Diagnostic (ultrasound elastography)
Patients undergo ultrasound elastography.
 Procedure: ultrasound elasticity imaging
Undergo ultrasound elastography


Outcome Measures
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Primary Outcome Measures :
  1. Strain ratio for all lesions measured by comparing the lesion to the adjacent normal tissue [ Time Frame: 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).


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908166


Locations
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United States, California
Stanford University, School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Juergen Willmann Stanford University Hospitals and Clinics
More Information
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Responsible Party: Juergen Willmann, Professor of Radiology, Stanford University
ClinicalTrials.gov Identifier: NCT01908166    
Other Study ID Numbers: VAR0099
NCI-2013-01353 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA124435 ( U.S. NIH Grant/Contract )
First Posted: July 25, 2013    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Kidney Neoplasms
Neoplasms by Site
Neoplasms
Urologic Neoplasms
 Urogenital Neoplasms
Kidney Diseases
Urologic Diseases