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

March 2, 2021 updated by: Bracco Diagnostics, Inc

A Pilot Clinical Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer by Molecular Imaging of VEGFR2

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

19

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • Service d'Imagerie Diagnostique et Interventionnelle de l'Adulte
  • United States
    • California
      • Stanford, California, United States, 94305
        • Translational Molecular Imaging Lab

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Within 30 minutes after administration of BR55

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events
Time Frame: 24 hours post-dose
To obtain safety data in subjects administered BR55
24 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bracco Diagnostics, Inc

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

May 16, 2014

First Submitted That Met QC Criteria

May 16, 2014

First Posted (Estimate)

May 20, 2014

Study Record Updates

Last Update Posted (Actual)

March 29, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BR55-105

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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