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

US Elastography for Characterizing Focal Lesions in the Liver and Kidney

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01908166

Enrollment

Registered

2013-07-25

Start date

2014-01-31

Completion date

2016-11-01

Last updated

2017-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Primary Liver Cancer, Kidney Tumor

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.

Interventions

PROCEDUREultrasound elasticity imaging

Undergo ultrasound elastography

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026