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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-01-31

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

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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.

Conditions

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Prostate Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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BR55

All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg...

Group Type EXPERIMENTAL

BR55

Intervention Type DRUG

Ultrasound contrast agent

Interventions

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BR55

Ultrasound contrast agent

Intervention Type DRUG

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

Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No