NCT05336786

Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Thomas Jefferson University · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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 70 patients within 30 days of their 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.

Conditions

• Prostate Carcinoma

Interventions

Type	Name	Description
DRUG	Perflutren Lipid Microspheres	Given IV
PROCEDURE	Ultrasound	Undergo ultrasound

Timeline

• Start date: 2022-06-15
• Primary completion: 2025-05-26
• Completion: 2026-05-26
• First posted: 2022-04-20
• Last updated: 2025-09-04

Locations

2 sites across 2 countries: United States, Netherlands

Regulatory

• FDA-regulated drug study