Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Tracking Information
First Submitted Date  ICMJE May 16, 2014
First Posted Date  ICMJE May 20, 2014
Results First Submitted Date  ICMJE August 11, 2020
Results First Posted Date  ICMJE August 27, 2020
Last Update Posted Date March 29, 2021
Study Start Date  ICMJE August 2014
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Prostate Cancer
Intervention  ICMJE Drug: BR55
Ultrasound contrast agent
Study Arms  ICMJE 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2016)
19
Original Estimated Enrollment  ICMJE
 (submitted: May 16, 2014)
21
Actual Study Completion Date  ICMJE January 2016
Actual Primary Completion Date July 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02142608
Other Study ID Numbers  ICMJE BR55-105
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bracco Diagnostics, Inc
Study Sponsor  ICMJE Bracco Diagnostics, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Maria Luigia Storto, M.D. Bracco Diagnostics, Inc
PRS Account Bracco Diagnostics, Inc
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP