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

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ClinicalTrials.gov Identifier: NCT02142608
Recruitment Status : Completed
First Posted : May 20, 2014
Results First Posted : August 27, 2020
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Study Description
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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

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: BR55 Phase 1 Phase 2

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot Clinical Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer by Molecular Imaging of VEGFR2
Study Start Date : August 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: BR55
All patients received BR55 as a single intravenous injection at the dose of 0.03 mL/kg...
 Drug: BR55
Ultrasound contrast agent


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of Participants With Adverse Events [ Time Frame: 24 hours post-dose ]
    To obtain safety data in subjects administered BR55


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male, age between 50-70 years old
  • Increased 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142608


Locations
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United States, California
Translational Molecular Imaging Lab
Stanford, California, United States, 94305
France
Service d'Imagerie Diagnostique et Interventionnelle de l'Adulte
Bordeaux, France
Sponsors and Collaborators
Bracco Diagnostics, Inc
Investigators
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Study Director: Maria Luigia Storto, M.D. Bracco Diagnostics, Inc
More Information
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Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT02142608    
Other Study ID Numbers: BR55-105
First Posted: May 20, 2014    Key Record Dates
Results First Posted: August 27, 2020
Last Update Posted: November 4, 2020
Last Verified: March 2015
Keywords provided by Bracco Diagnostics, Inc:
Prostate cancer
Ultrasound Imaging
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases