Back to Search Results- Recruiting
- Diagnostic
- Interventional
- Drug & Procedure
- PHASE3
- Thomas Jefferson University
- 18 Years -
Study Purpose
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.
Intervention
Drug : Perflutren Lipid Microspheres
Procedure : Ultrasound
Eligibility Requirements
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
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
Recruiting status
Recruiting
Estimated enrollment
70
Study start date
Jun 15, 2022
Study end date
May 26, 2026
Last updated
Mar 23, 2025
Primary purpose
Diagnostic
Design
Interventional
Intervention
Drug & Procedure
Study phase
PHASE3
Allocation
Na
Sponsor:
Thomas Jefferson University
Collaborator:
N/A
Investigator:
N/A
N/A
Publications
N/A
Websites
N/A
NCT05336786
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