BR55 in Prostate Cancer: an Exploratory Clinical Trial

This study has been completed.
Sponsor:
Collaborator:
Bracco Imaging SpA
Information provided by (Responsible Party):
Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01253213
First received: December 2, 2010
Last updated: April 23, 2013
Last verified: April 2013
  Purpose

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).


Condition Intervention Phase
Prostate Cancer
Drug: BR55
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Exploratory Clinical Trial Using BR55 Targeted Ultrasound Contrast Agent in the Detection of Prostate Cancer by Molecular Imaging of VEGFR2

Resource links provided by NLM:


Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:
  • BR55 sensitivity assessment [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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.


Enrollment: 26
Study Start Date: July 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BR55 Drug: BR55
One to two bolus (2nd bolus optional) of BR55 per patient

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253213

Locations
Netherlands
AMC University Amsterdam
Amsterdam, Netherlands, 1100 DD
Sponsors and Collaborators
Bracco Diagnostics, Inc
Bracco Imaging SpA
Investigators
Principal Investigator: Hessel Wijkstra, Dr. Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  More Information

No publications provided

Responsible Party: Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT01253213     History of Changes
Other Study ID Numbers: BR55-101
Study First Received: December 2, 2010
Last Updated: April 23, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Bracco Diagnostics, Inc:
Prostate cancer
Ultrasound molecular imaging
Contrast agent
BR55
VEGFR2

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2014