Education and Training

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

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

Stanford is currently not accepting patients for this trial.

Intervention(s):

  • drug: BR55

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

Ages Eligible for Study

50 Years - 70 Years

Genders Eligible for Study

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting