An Imaging Agent (Perflutren Lipid Microspheres) With Ultrasound for Imaging of Prostate Cancer

• Status: Not yet recruiting
• Trial end date: 2026-05-26
• Target enrollment: 0
• Participant gender: Male

Summary

This phase III trial investigates if perflutren lipid microspheres with ultrasound can be used to diagnose prostate cancer non-invasively. Definity (perflutren lipid microspheres) is an ultrasound contrast agent that is typically used for ultrasound bubble studies that involve the heart. Definity appears on ultrasound images as tiny gas-filled microbubbles. These microbubbles are about the size of a red blood cell and do not stay in a patient's body for more than several minutes, where they are excreted from the lungs and exhaled back into the air when breathing. Definity may enhance ultrasound images of the prostate and help doctors identify prostate cancer on ultrasound images.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University

Criteria

Inclusion Criteria:

• Subject must be scheduled for radical prostatectomy for treatment of prostate cancer

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

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

Exclusion Criteria:

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

• Patients with known or suspected hypersensitivity to perflutren, PEG, or any other component of Definity

• Previous treatment for prostate cancer, including hormone therapy

• Clinically unstable, severely ill, or moribund as per treating physician