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

Prostate Carcinoma Clinical Trial

Official title:

Evaluation of the Aixplorer Ultrasound System for Evaluation of the Prostate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03013413
• Other study ID #: 11D.349
• 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

• Prostate Carcinoma
• Prostatic Neoplasms

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

External Links

•   Sidney Kimmel Cancer Center
•   Thomas Jefferson University Hospital