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

NCT01908166 | Completed

• 3 other identifiers: VAR0099NCI-2013-01353P30CA124435
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Adult Primary Liver Cancer; Kidney Tumor

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to 36 months

Study Arms (1)

Diagnostic (ultrasound elastography)

EXPERIMENTAL

Patients undergo ultrasound elastography.

Procedure: ultrasound elasticity imaging

Interventions

ultrasound elasticity imaging PROCEDURE

Undergo ultrasound elastography

Diagnostic (ultrasound elastography)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Juergen Willmann

  Stanford University Hospitals and Clinics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: July 23, 2013
• First Posted: July 25, 2013
• Study Start: January 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: June 8, 2017

Record last verified: 2017-06

Locations

US (1)