A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer
Trial ID or NCT#
NCT02142608
Status
NOT RECRUITING
Purpose
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
Eligibility Criteria
Ages Eligible for Study: 50 Years to 70 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: Yes
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
Investigator(s)
Sanjiv Sam Gambhir, MD, PhD
Geoffrey Sonn
Urologic oncologist,
Urologist,
Urologic specialist,
Genitourinary specialist,
Urologic surgeon
Associate Professor of Urology and, by courtesy, of Radiology (Body MRI)
Contact us to find out if this trial is right for you.
Contact
CCTO
650-498-7061
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