Detection of High Grade Prostate Cancer With Subharmonic Ultrasound Imaging, A Pilot Study

• Status: Completed
• Trial end date: 2018-09-20
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Collaborator: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

1. 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.

2. Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate.

3. Subject must be a male at least 18 years of age when informed consent is obtained.

4. Subject must have a life expectancy that exceeds the duration of the clinical trial.

Exclusion Criteria:

1. Participant in a clinical trial involving an investigational drug within the past 30 days.

2. Prior allergic reaction to the ultrasound contrast agent Definity™

3. Previous treatment for PCa.

4. Clinically unstable, severely ill, or moribund.