Detection of High Grade Prostate Cancer With Subharmonic Ultrasound Imaging, A Pilot Study
Status:
Completed
Trial end date:
2018-09-20
Target enrollment:
Participant gender:
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.