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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02142608
• Other study ID #: BR55-105
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2014
• Est. completion date: January 2016

Study information

• Verified date: March 2021
• Source: Bracco Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: January 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years to 70 Years

Eligibility

Inclusion Criteria:

• Male, age between 50-70 years old

• Increased Prostate-Specific Antigen (PSA) level >4 ng/mL

• Known prostate cancer

• Scheduled for prostatectomy not earlier than 3 days and not later than 30 days following BR55 administration (with the exception of training cases where this requirement is not applicable)

• Provided written informed consent and willing to comply with protocol requirements

Exclusion Criteria:

• Documented acute prostatitis or urinary tract infections

• Known to suffer from stable angina pectoris and/or proven coronary disease, or have symptoms suspicious of coronary disease

• History of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to left shunts

• Severe cardiac rhythm disorders within the last 7 days

• Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome

• Received a prostate biopsy procedure within 30 days before admission into the study

• Determined by investigator to be clinically unsuitable for the study

• Participated in a concurrent clinical trial or has participated in another clinical trial with an investigational compound within the past 30 days

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• BR55
Ultrasound contrast agent

Locations

Country	Name	City	State
France	Service d'Imagerie Diagnostique et Interventionnelle de l'Adulte	Bordeaux
United States	Translational Molecular Imaging Lab	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Bracco Diagnostics, Inc

Countries where clinical trial is conducted

United States,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 30 minutes after administration of BR55
Secondary	Number of Participants With Adverse Events	To obtain safety data in subjects administered BR55	24 hours post-dose