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

Not Recruiting

Trial ID: NCT02142608


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

Official Title

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

Stanford Investigator(s)

Geoffrey Sonn
Geoffrey Sonn

Associate Professor of Urology and, by courtesy, of Radiology (Body MRI)

James D. Brooks
James D. Brooks

Keith and Jan Hurlbut Professor


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


drug: BR55

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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