Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy

January 4, 2017 updated by: Sidney Kimmel Cancer Center at Thomas Jefferson University

Evaluation of the Aixplorer Ultrasound System for Evaluation of the Prostate

This clinical trial studies an ultrasound-based imaging procedure called elastography using the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. Elastography uses ultrasound imaging techniques to examine the stiffness or elasticity of a tissue and may enhance the detection of prostate cancer. It is not yet known whether elastography imaging using the Aixplorer system works better than standard ultrasound imaging in detecting prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate the detection of prostate cancer with elastography using the Aixplorer scanner.

SECONDARY OBJECTIVES:

I. To obtain quantitative data on the elastic properties of normal and malignant tissue in the prostate of patients referred for ultrasound guided biopsy.

II. To compare the Gleason grade of prostate cancers detected with elastography to the Gleason grade of tumors detected by conventional systematic biopsy.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Be scheduled for a clinically indicated biopsy of the prostate
  • Agree to an ultrasound examination using the Aixplorer system
  • Sign an institutional review board (IRB) approved informed consent prior to any study procedures

Exclusion Criteria:

• Recent prostate biopsy within 90 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (elastography imaging using the Aixplorer system)
Patients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes.
Procedure: Shear Wave Elastography
Undergo ultrasound-based elastography imaging using the Aixplorer system
Other Names:
  • Transient Elastography
Procedure: Ultrasound Elasticity Imaging
Undergo ultrasound-based elastography imaging using the Aixplorer system
Procedure: Ultrasound-Guided Prostate Biopsy
Undergo standard of care ultrasound-guided prostate biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner
Time Frame: At the time of prostate biopsy
Will focus on comparing the frequency of diagnosis of prostate cancer between conventional systematic biopsy and targeted biopsy based upon abnormalities in gray scale imaging, Doppler imaging, and elastography. The main parameter of interest will be the ratio of the detection frequency with targeted biopsy versus that with systematic biopsy. The analyses will be based on methods for matched data in cohort studies and will use the appropriate estimate and variance for the relative risk.
At the time of prostate biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gleason scores of the cores detected with targeted biopsy versus those of the cores of systematic biopsy
Time Frame: At the time of prostate biopsy
Analyses will be carried out via the Generalized Estimating Equations methods to account for clustering within patient (multiple cores per patient).
At the time of prostate biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Cancer Center at Thomas Jefferson University

Investigators

  • Principal Investigator: Ethan Halpern, MD, Thomas Jefferson University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

January 4, 2017

First Submitted That Met QC Criteria

January 4, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Estimate)

January 6, 2017

Last Update Submitted That Met QC Criteria

January 4, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11D.349

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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