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

Primary Purpose

Prostate Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shear Wave Elastography
Ultrasound Elasticity Imaging
Ultrasound-Guided Prostate Biopsy
Sponsored by
Sidney Kimmel Cancer Center at Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Thomas Jefferson University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (elastography imaging using the Aixplorer system)

Arm Description

Patients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes.

Outcomes

Primary Outcome Measures

Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner
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.

Secondary Outcome Measures

Gleason scores of the cores detected with targeted biopsy versus those of the cores of systematic biopsy
Analyses will be carried out via the Generalized Estimating Equations methods to account for clustering within patient (multiple cores per patient).

Full Information

First Posted
January 4, 2017
Last Updated
January 4, 2017
Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT03013413
Brief Title
Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy
Official Title
Evaluation of the Aixplorer Ultrasound System for Evaluation of the Prostate
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Cancer Center at Thomas Jefferson University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (elastography imaging using the Aixplorer system)
Arm Type
Experimental
Arm Description
Patients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes.
Intervention Type
Procedure
Intervention Name(s)
Shear Wave Elastography
Other Intervention Name(s)
Transient Elastography
Intervention Description
Undergo ultrasound-based elastography imaging using the Aixplorer system
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Elasticity Imaging
Intervention Description
Undergo ultrasound-based elastography imaging using the Aixplorer system
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-Guided Prostate Biopsy
Intervention Description
Undergo standard of care ultrasound-guided prostate biopsy
Primary Outcome Measure Information:
Title
Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner
Description
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.
Time Frame
At the time of prostate biopsy
Secondary Outcome Measure Information:
Title
Gleason scores of the cores detected with targeted biopsy versus those of the cores of systematic biopsy
Description
Analyses will be carried out via the Generalized Estimating Equations methods to account for clustering within patient (multiple cores per patient).
Time Frame
At the time of prostate biopsy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ethan Halpern, MD
Organizational Affiliation
Thomas Jefferson University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States

12. IPD Sharing Statement

Links:
URL
http://hospitals.jefferson.edu/
Description
Thomas Jefferson University Hospital

Learn more about this trial

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

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