NCT03013413

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

Evaluation of the Aixplorer Ultrasound System for Evaluation of the Prostate

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Shear Wave Elastography	Undergo ultrasound-based elastography imaging using the Aixplorer system
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

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2017-01-06
• Last updated: 2025-05-02

Locations

1 site across 1 country: United States