Trial Search Results

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

Ultrasound is a diagnostic imaging test widely used to diagnose many diseases in the body. A rectal ultrasound examination is a safe and routinely used diagnostic method which images the prostate through the rectum. BR55 is a new experimental ultrasound contrast agent. BR55 has been developed for use as a contrast agent to make the images created using ultrasound equipment clearer to see and understand. The purpose of this research study is to demonstrate whether an ultrasound with BR55 will make any lesions in the prostate more visible.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Bracco Diagnostics, Inc

Intervention(s):

  • Drug: BR55

Phase:

Phase 1/Phase 2

Eligibility


Inclusion Criteria:

   - Male, age between 50-70 years old

   - Increased 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)

   - Provides 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

   - Participating 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