Prostate Carcinoma Clinical Trial
Official title:
Evaluation of the Aixplorer Ultrasound System for Evaluation of the Prostate
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.
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.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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