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BR55 in Prostate Cancer: an Exploratory Clinical Trial

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Early Phase 1
Locations
Netherlands
Study Type
Interventional
Intervention
BR55
Sponsored by
Bracco Diagnostics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate cancer, Ultrasound molecular imaging, Contrast agent, BR55, VEGFR2

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Male patient, age ≥ 40 years old
  • Has a histology proven focal prostate cancer lesion
  • The patient is already scheduled for prostatectomy not earlier than 3 days and at the latest 15 days after BR55 administration
  • Provides written Informed Consent and is willing to comply with protocol requirement

Exclusion Criteria:

  • Has a body weight greater than 95 kg (this weight limitation is required in order to maintain the active component of the drug under 100μg) according to the indication of the EMEA guideline M3 for this type of study
  • Has documented acute prostatitis or urinary tract infections
  • Is known to suffer from stable angina pectoris and/or proven coronary disease, or to have symptoms suspicious of coronary disease
  • With history of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to-left shunts
  • Has had severe cardiac rhythm disorders within the last 7 days
  • Has severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
  • Has received a prostate biopsy procedure within 30 days before admission into this study
  • Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study.
  • Is determined by the Investigator that the patient is clinically unsuitable for the study.
  • Is incapable of understanding the language in which the information for the patient is given
  • Participation in a concurrent clinical trial or in another trial with an investigational compound within the past 30 days;

Sites / Locations

  • AMC University Amsterdam

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BR55

Arm Description

Outcomes

Primary Outcome Measures

BR55 sensitivity assessment
Assess the ability of BR55 to identify area(s) of VEGFR2 expression in human prostate by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology analysis (location based on expression of VEGFR2 in tissue specimens determined by immuno-histochemistry, IHC).

Secondary Outcome Measures

BR55 specificity assessment
Evaluate the specificity of BR55 targeting for prostate cancer relative to normal prostate gland on the basis of a visual score in comparison with routine histopathology analysis and IHC assessment of VEGFR2 expression in tissue specimens.

Full Information

First Posted
December 2, 2010
Last Updated
July 31, 2023
Sponsor
Bracco Diagnostics, Inc
Collaborators
Bracco Imaging S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01253213
Brief Title
BR55 in Prostate Cancer: an Exploratory Clinical Trial
Official Title
Exploratory Clinical Trial Using BR55 Targeted Ultrasound Contrast Agent in the Detection of Prostate Cancer by Molecular Imaging of VEGFR2
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bracco Diagnostics, Inc
Collaborators
Bracco Imaging S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether BR55 is able to identify areas of VEGFR2 expression in human prostate by ultrasound molecular imaging. This will be compared with histopathology analysis (location based on expression of VEGFR2 in tissue specimens determined by immuno-histochemistry, IHC).

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 molecular imaging, Contrast agent, BR55, VEGFR2

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BR55
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BR55
Intervention Description
One to two bolus (2nd bolus optional) of BR55 per patient
Primary Outcome Measure Information:
Title
BR55 sensitivity assessment
Description
Assess the ability of BR55 to identify area(s) of VEGFR2 expression in human prostate by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology analysis (location based on expression of VEGFR2 in tissue specimens determined by immuno-histochemistry, IHC).
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
BR55 specificity assessment
Description
Evaluate the specificity of BR55 targeting for prostate cancer relative to normal prostate gland on the basis of a visual score in comparison with routine histopathology analysis and IHC assessment of VEGFR2 expression in tissue specimens.
Time Frame
Day 1

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male patient, age ≥ 40 years old Has a histology proven focal prostate cancer lesion The patient is already scheduled for prostatectomy not earlier than 3 days and at the latest 15 days after BR55 administration Provides written Informed Consent and is willing to comply with protocol requirement Exclusion Criteria: Has a body weight greater than 95 kg (this weight limitation is required in order to maintain the active component of the drug under 100μg) according to the indication of the EMEA guideline M3 for this type of study Has documented acute prostatitis or urinary tract infections Is known to suffer from stable angina pectoris and/or proven coronary disease, or to have symptoms suspicious of coronary disease With history of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to-left shunts Has had severe cardiac rhythm disorders within the last 7 days Has severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome Has received a prostate biopsy procedure within 30 days before admission into this study Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study. Is determined by the Investigator that the patient is clinically unsuitable for the study. Is incapable of understanding the language in which the information for the patient is given Participation in a concurrent clinical trial or in another trial with an investigational compound within the past 30 days;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hessel Wijkstra, Dr.
Organizational Affiliation
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
AMC University Amsterdam
City
Amsterdam
ZIP/Postal Code
1100 DD
Country
Netherlands

12. IPD Sharing Statement

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BR55 in Prostate Cancer: an Exploratory Clinical Trial

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