A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer
Conditions
Prostate Cancer
Conditions: official terms
Prostatic Neoplasms
Conditions: Keywords
Prostate cancer, Ultrasound Imaging
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: BR55
Type: Drug
Overall Status
Recruiting
Summary
Pilot study to evaluate the sensitivity and specificity of BR55 targeting for prostate cancer nodules with Gleason score greater than or equal to 7.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 50 Years
Gender: Male
Criteria: 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
Location
Stanford University Medical Center
Palo Alto, California, United States
Status: Recruiting
Start Date
August 2014
Completion Date
June 2015
Sponsors
Bracco Diagnostics, Inc
Source
Bracco Diagnostics, Inc
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page