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BR55 in Prostate Cancer: an Exploratory Clinical Trial

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: NCT01253213
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : April 24, 2013
Sponsor:
Collaborator:
Bracco Imaging S.p.A.
Information provided by (Responsible Party):
Bracco Diagnostics, Inc

Tracking Information
First Submitted Date  ICMJE December 2, 2010
First Posted Date  ICMJE December 3, 2010
Last Update Posted Date April 24, 2013
Study Start Date  ICMJE July 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2010)
BR55 sensitivity assessment [ Time Frame: Day 1 ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2010)
BR55 specificity assessment [ Time Frame: Day 1 ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BR55 in Prostate Cancer: an Exploratory Clinical Trial
Official Title  ICMJE Exploratory Clinical Trial Using BR55 Targeted Ultrasound Contrast Agent in the Detection of Prostate Cancer by Molecular Imaging of VEGFR2
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
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
One to two bolus (2nd bolus optional) of BR55 per patient
Study Arms  ICMJE Experimental: BR55
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: April 23, 2013)
26
Original Estimated Enrollment  ICMJE
 (submitted: December 2, 2010)
12
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years and older   (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 Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01253213
Other Study ID Numbers  ICMJE BR55-101
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 Bracco Imaging S.p.A.
Investigators  ICMJE
Principal Investigator: Hessel Wijkstra, Dr. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PRS Account Bracco Diagnostics, Inc
Verification Date April 2013

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