Status:
ACTIVE_NOT_RECRUITING
Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)
Lead Sponsor:
Thomas Jefferson University
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Carcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE3
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 con...
Detailed Description
PRIMARY OBJECTIVES: I. To collect multiparametric ultrasound (mp-US) data on 70 patients within 30 days of their radical prostatectomy. II. To correlate the imaging data with whole mount prostatecto...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 26 2026
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT05336786
Start Date
June 15 2022
End Date
May 26 2026
Last Update
September 4 2025
Active Locations (2)
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1
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
2
Amsterdam University Medical Centers
Amsterdam, Netherlands