Back to resultsA Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BR55
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate cancer, Ultrasound Imaging
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
Sites / Locations
- Translational Molecular Imaging Lab
- Service d'Imagerie Diagnostique et Interventionnelle de l'Adulte
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BR55
Arm Description
All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg...
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of Participants With Adverse Events
To obtain safety data in subjects administered BR55
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02142608
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bracco Diagnostics, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, Ultrasound Imaging
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BR55
Arm Type
Experimental
Arm Description
All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg...
Intervention Type
Drug
Intervention Name(s)
BR55
Intervention Description
Ultrasound contrast agent
Primary Outcome Measure Information:
Title
Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging
Description
To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard
Time Frame
Within 30 minutes after administration of BR55
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
To obtain safety data in subjects administered BR55
Time Frame
24 hours post-dose
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Luigia Storto, M.D.
Organizational Affiliation
Bracco Diagnostics, Inc
Official's Role
Study Director
Facility Information:
Facility Name
Translational Molecular Imaging Lab
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Service d'Imagerie Diagnostique et Interventionnelle de l'Adulte
City
Bordeaux
Country
France
12. IPD Sharing Statement
Learn more about this trial
A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer
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