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

Completed · Phase 1/Phase 2

Conditions studied: Prostate Cancer

In brief

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

Key facts

Study ID

NCT02142608

Run by

Bracco Diagnostics, Inc

People needed

19

Starts

2014-08-01

Expected to finish

2016-01-01

Last updated by the study team

2021-03-29

Who can join

Age: 50 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Translational Molecular Imaging Lab — Stanford, California, United States
• Service d'Imagerie Diagnostique et Interventionnelle de l'Adulte — Bordeaux, France

Full record on ClinicalTrials.gov

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