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

• ClinicalTrials.gov Identifier: NCT02142608
• Recruitment Status: Completed
• First Posted: May 20, 2014
• Results First Posted: August 27, 2020
• Last Update Posted: March 29, 2021
• Sponsor: Bracco Diagnostics, Inc
• Information provided by (Responsible Party): Bracco Diagnostics, Inc

Tracking Information

• First Submitted Date: May 16, 2014
• First Posted Date: May 20, 2014
• Results First Submitted Date: August 11, 2020
• Results First Posted Date: August 27, 2020
• Last Update Posted Date: March 29, 2021
• Study Start Date: August 2014
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: October 14, 2020)

Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging [ Time Frame: 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

Original Primary Outcome Measures (submitted: May 16, 2014)

Sensitivity and specificity of BR55 [ Time Frame: Within 30 minutes after administration of BR55 ]

Using a visual score of ultrasound molecular imaging (USMI) when compared to histopathology results, the sensitivity and specificity of BR55 targeting for prostate cancer nodules with a gleason score that is greater than or equal to 7 will be an outcome measure assessed in this study

Current Secondary Outcome Measures (submitted: August 11, 2020)

Number of Participants With Adverse Events [ Time Frame: 24 hours post-dose ]

To obtain safety data in subjects administered BR55

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer
• Official Title: A Pilot Clinical Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer by Molecular Imaging of VEGFR2
• 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 Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Prostate Cancer

Intervention

Drug: BR55

Ultrasound contrast agent

Study Arms

Experimental: BR55

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

Intervention: Drug: BR55

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 3, 2016): 19
• Original Estimated Enrollment (submitted: May 16, 2014): 21
• Actual Study Completion Date: January 2016
• Actual Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 50 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France, United States

Administrative Information

• NCT Number: NCT02142608
• Other Study ID Numbers: BR55-105
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Bracco Diagnostics, Inc
• Study Sponsor: Bracco Diagnostics, Inc
• Collaborators: Not Provided

Investigators

• Study Director: Maria Luigia Storto, M.D.; Bracco Diagnostics, Inc

• PRS Account: Bracco Diagnostics, Inc
• Verification Date: March 2021