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
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
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
19
Ultrasound contrast agent
Translational Molecular Imaging Lab
Stanford, California, United States
Service d'Imagerie Diagnostique et Interventionnelle de l'Adulte
Bordeaux, France
Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging
To assess the ability of BR55 to identify prostate cancer lesions with a Gleason score ≥ 7 using histopathology as truth standard
Time frame: Within 30 minutes after administration of BR55
Number of Participants With Adverse Events
To obtain safety data in subjects administered BR55
Time frame: 24 hours post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.