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

• Status: Completed
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: Male

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bracco Diagnostics, Inc

Criteria

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