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

Primary Purpose

Adult Primary Liver Cancer, Kidney Tumor

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ultrasound elasticity imaging
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adult Primary Liver Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University, School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (ultrasound elastography)

Arm Description

Patients undergo ultrasound elastography.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
July 23, 2013
Last Updated
June 6, 2017
Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01908166
Brief Title
Ultrasound Elastography in Diagnosing Patients With Kidney or Liver Solid Focal Lesions
Official Title
US Elastography for Characterizing Focal Lesions in the Liver and Kidney
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
November 1, 2016 (Actual)
Study Completion Date
November 1, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Primary Liver Cancer, Kidney Tumor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (ultrasound elastography)
Arm Type
Experimental
Arm Description
Patients undergo ultrasound elastography.
Intervention Type
Procedure
Intervention Name(s)
ultrasound elasticity imaging
Intervention Description
Undergo ultrasound elastography
Primary Outcome Measure Information:
Title
Strain ratio for all lesions measured by comparing the lesion to the adjacent normal tissue
Description
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).
Time Frame
Up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juergen Willmann
Organizational Affiliation
Stanford University Hospitals and Clinics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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

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