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Brief Title: Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)
Official Title: Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)
Study ID: NCT05336786
Brief 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.
Detailed Description: PRIMARY OBJECTIVES: I. To collect multiparametric ultrasound (mp-US) data on 50 patients \> 3 days prior to radical prostatectomy. II. To correlate the imaging data with whole mount prostatectomy specimens in order to optimize mp-US with a machine learning approach. OUTLINE: Patients receive perflutren lipid microspheres intravenously (IV) over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres during ultrasound. After completion of study, patients are followed up for 30 days.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Sidney Kimmel Cancer Center at Thomas Jefferson University, Philadelphia, Pennsylvania, United States
Amsterdam University Medical Centers, Amsterdam, , Netherlands