NCT02142608

A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer

A Pilot Clinical Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer by Molecular Imaging of VEGFR2

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Bracco Diagnostics, Inc · Industry
• Sex: Male
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	BR55	Ultrasound contrast agent

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-07-01
• Completion: 2016-01-01
• First posted: 2014-05-20
• Last updated: 2021-03-29
• Results posted: 2020-08-27

Locations

2 sites across 2 countries: United States, France