An Imaging Agent (Perflutren Lipid Microspheres) With Ultrasound for Imaging of Prostate Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)

Conditions
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Prostate Carcinoma

Intervention / Treatment
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* Drug: Perflutren Lipid Microspheres
* Procedure: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (perflutren lipid microspheres, ultrasound)<br>Patients receive perflutren lipid microspheres IV over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres | Drug: Perflutren Lipid Microspheres<br>* Given IV<br>* Other names: Definity;Procedure: Ultrasound<br>* Undergo ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate |  | Up to 12 months |