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

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Drug: BR55

• Registration Number: NCT02142608
• Lead Sponsor: Bracco Diagnostics, Inc

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-05-16
• Study First Submitted QC: 2014-05-16
• Study First Posted: 2014-05-20
• Study Start: 2014-08
• Primary Completion: 2015-07
• Study Completion: 2016-01
• Results First Submitted: 2020-08-11
• Results First Submitted QC: 2020-08-11
• Results First Posted: 2020-08-27
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	24 hours post-dose	To obtain safety data in subjects administered BR55

Trial Locations

Locations (2)

Translational Molecular Imaging Lab; 🇺🇸 Stanford, California, United States

Service d'Imagerie Diagnostique et Interventionnelle de l'Adulte; 🇫🇷 Bordeaux, France