Detection of High Grade Prostate Cancer With Subharmonic Ultrasound Imaging, A Pilot Study
Prostatic Neoplasm
About this trial
This is an interventional diagnostic trial for Prostatic Neoplasm focused on measuring prostate cancer, prostate ultrasound, subharmonic imaging, prostate biopsy
Eligibility Criteria
Inclusion Criteria:
- Subject must be scheduled for a clinically indicated needle biopsy of the prostate based upon an elevated PSA, abnormal digital rectal examination, or based upon active surveillance of prostate cancer.
- Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate.
- Subject must be a male at least 18 years of age when informed consent is obtained.
- Subject must have a life expectancy that exceeds the duration of the clinical trial.
Exclusion Criteria:
- Participant in a clinical trial involving an investigational drug within the past 30 days.
- Prior allergic reaction to the ultrasound contrast agent Definity™
- Previous treatment for PCa.
- Clinically unstable, severely ill, or moribund.
Sites / Locations
- Thomas Jefferson University Hospital
Arms of the Study
Arm 1
Experimental
Prostate Biopsy Patients
Fifty patients who are scheduled for a clinically indicated prostate biopsy, and who are able to undergo contrast enhanced transrectal ultrasound will be included in this single arm study. Each of the study subjects will receive in intravenous infusion of a microbubble contrast agent known as Definity™, (Perflutren Lipid Microsphere, Lantheus Medical Imaging, Inc; N. Billerica, MA). Based upon our previous experience, two vials of Perflutren Lipid Microsphere will be mixed and diluted in 50 ml of normal saline, yielding a concentration of 49.4 μl/ml. For the purpose of contrast-enhanced imaging, Perflutren Lipid Microsphere will be infused over approximately 10-12 minutes, during which time ultrasound imaging and biopsy will be performed.