Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)
Running, not enrolling · Phase 3
Conditions studied: Prostate Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05336786
- Run by
- Thomas Jefferson University
- People needed
- 70
- Starts
- 2022-06-15
- Expected to finish
- 2026-05-26
- Last updated by the study team
- 2025-09-04
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States
- Amsterdam University Medical Centers — Amsterdam, Netherlands
Full record on ClinicalTrials.gov
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