A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer

Study Overview
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Brief Summary
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Pilot study to evaluate the ability of BR55 to identify prostate cancer lesions with Gleason Score ≥7 by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology results

Detailed Description
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This multi-centre, open label, prospective, pilot study was designed to assess the ability of BR55 to detect VEGFR2 in human prostate cancer by Ultrasound Molecular Imaging (USMI). The binding of BR55 to VEGFR2 (focal enhancement still visible after significant decrease in signal from circulating microbubbles seen) was assessed at USMI and VEGFR2 expression was to be confirmed by immunohistochemistry (IHC) analysis including VEGFR2 and CD31 staining.

Official Title
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A Pilot Clinical Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer by Molecular Imaging of VEGFR2

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: BR55


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male, age between 50-70 years old Increased Prostate-Specific Antigen (PSA) level >4 ng/mL Known prostate cancer Scheduled for prostatectomy not earlier than 3 days and not later than 30 days following BR55 administration (with the exception of training cases where this requirement is not applicable) Provided written informed consent and willing to comply with protocol requirements Exclusion Criteria: Documented acute prostatitis or urinary tract infections Known to suffer from stable angina pectoris and/or proven coronary disease, or have symptoms suspicious of coronary disease History of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to left shunts Severe cardiac rhythm disorders within the last 7 days Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome Received a prostate biopsy procedure within 30 days before admission into the study Determined by investigator to be clinically unsuitable for the study Participated in a concurrent clinical trial or has participated in another clinical trial with an investigational compound within the past 30 days

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 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: BR55<br>All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg... | Drug: BR55<br>* Ultrasound contrast agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging | To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard | Within 30 minutes after administration of BR55 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events | To obtain safety data in subjects administered BR55 | 24 hours post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, Ultrasound Imaging