Clinical trial NCT02142608: A Pilot Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer
Official title: A Pilot Clinical Trial Using BR55 Ultrasound Contrast Agent in the Assessment of Prostate Cancer by Molecular Imaging of VEGFR2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostate cancer
Ultrasound Imaging
Lead sponsor: Bracco Diagnostics, Inc
Sponsor class: INDUSTRY
First posted: 2014-05-20
Enrollment: 19
Sex: MALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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

Detailed description: This multi-centre, open label, prospective, pilot study was designed to assess the ability of BR55 to detect VEGFR2 in human prostate cancer by Ultrasound Molecular Imaging (USMI). The binding of BR55 to VEGFR2 (focal enhancement still visible after significant decrease in signal from circulating microbubbles seen) was assessed at USMI and VEGFR2 expression was to be confirmed by immunohistochemistry (IHC) analysis including VEGFR2 and CD31 staining.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Lesions With Gleason Score ≥ 7 Identified by Ultrasound Molecular Imaging
timeFrame: Within 30 minutes after administration of BR55
Secondary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 24 hours post-dose
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Translational Molecular Imaging Lab
state: California
city: Bordeaux
country: France
facility: Service d'Imagerie Diagnostique et Interventionnelle de l'Adulte
Study officials:
affiliation: Bracco Diagnostics, Inc
name: Maria Luigia Storto, M.D.
role: STUDY_DIRECTOR
References: