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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03013413
Other study ID # 11D.349
Secondary ID
Status Completed
Phase N/A
First received January 4, 2017
Last updated January 4, 2017
Start date September 2011
Est. completion date May 2014

Study information

Verified date January 2017
Source Thomas Jefferson University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Procedure:
Shear Wave Elastography
Undergo ultrasound-based elastography imaging using the Aixplorer system
Ultrasound Elasticity Imaging
Undergo ultrasound-based elastography imaging using the Aixplorer system
Ultrasound-Guided Prostate Biopsy
Undergo standard of care ultrasound-guided prostate biopsy

Locations

Country Name City State
United States Thomas Jefferson University Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Sidney Kimmel Cancer Center at Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At the time of prostate biopsy No
Secondary 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). At the time of prostate biopsy No
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