Skip to main content
OpenTrials
Completed

NCT Number: NCT01908166

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adult Primary Liver Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Carcinoma, Renal Cell Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Kidney Tumor Liver Diseases Liver Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University, School of Medicine

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound elasticity imaging

Procedure

Undergo ultrasound elastography

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

US Elastography for Characterizing Focal Lesions in the Liver and Kidney

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 25, 2013
Registry last updated
Jun 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.