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

Sidney Kimmel Cancer Center at Thomas Jefferson University

Status: Completed

Conditions: Prostate Carcinoma

Treatments: Procedure: Ultrasound-Guided Prostate Biopsy; Procedure: Ultrasound Elasticity Imaging; Procedure: Shear Wave Elastography

Study type: Interventional

Funder types: Other

Identifiers

NCT03013413

JT 1614 (Other Identifier)

11D.349

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: Male

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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99 participants in 1 patient group

Diagnostic (elastography imaging using the Aixplorer system)

Experimental group

Description:

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

Treatment:

Procedure: Ultrasound Elasticity Imaging

Procedure: Shear Wave Elastography

Procedure: Ultrasound-Guided Prostate Biopsy