At a glance
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Detection of High Grade Prostate Cancer With Subharmonic Ultrasound Imaging, A Pilot Study
In Brief
A Phase 2 clinical trial evaluating Perflutren Lipid Microsphere Intravenous Suspension for Prostatic Neoplasm. Completed, enrolled 55 participants across 1 site.
Detailed Summary
This is a phase II single center study using contrast-enhanced ultrasound to identify aggressive forms of prostate cancer with subharmonic imaging. The following are the study objectives: 1. To implement subharmonic imaging technology on a transrectal probe suitable for prostate imaging and biopsy 2. To demonstrate visualization of prostatic vascularity using subharmonic contrast-enhanced imaging. 3. To provide a preliminary estimate of the diagnostic accuracy of contrast-enhanced subharmonic imaging for detection of clinically significant PCa. The study will include 50 subjects who are scheduled for prostate biopsy. Each subject will receive an intravenous infusion of microbubble contrast material immediately prior to a prostate biopsy procedure. The study will demonstrate whether subharmonic imaging with a microbubble contrast agent allows for detection of clinically significant prostate cancer.
Study Details
Timeline
Interventions
The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound imaging. This enhancement will be used to guide targeted biopsy of the prostate to vascular areas which are more likely to contain aggressive prostate cancer.