BR55 in Prostate Cancer: an Exploratory Clinical Trial
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|ClinicalTrials.gov Identifier: NCT01253213|
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : April 24, 2013
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: BR55||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exploratory Clinical Trial Using BR55 Targeted Ultrasound Contrast Agent in the Detection of Prostate Cancer by Molecular Imaging of VEGFR2|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||December 2012|
|Actual Study Completion Date :||December 2012|
One to two bolus (2nd bolus optional) of BR55 per patient
- 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).
- 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.
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): NCT01253213
|AMC University Amsterdam|
|Amsterdam, Netherlands, 1100 DD|
|Principal Investigator:||Hessel Wijkstra, Dr.||Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)|