EXPLORATORY CLINICAL TRIAL USING BR55 TARGETED ULTRASOUND CONTRAST AGENT IN THE DETECTION OF PROSTATE CANCER BY MOLECULAR IMAGING OF VEGFR2

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 12

Inclusion Criteria

* Male patient, age * 40 years old
* Has a histology proven focal prostate cancer lesion
* The patient is already scheduled for prostatectomy not earlier than 3 days and at the latest 15 days after BR55 administration
* Provides written Informed Consent and is willing to comply with protocol requirements

Exclusion Criteria

* Has a body weight greater than 95 kg (this weight limitation is required in order to maintain the active component of the drug under 100*g) according to the indication of the EMEA guideline M3 for this type of study
* Has documented acute prostatitis or urinary tract infections
* With history of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to-left shunts
* Has had severe cardiac rhythm disorders within the last 7 days
* Has severe pulmonary hypertension (pulmonary artery pressure >90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
* Has received a prostate biopsy procedure within 30 days before admission into this study
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study.
* Is determined by the Investigator that the patient is clinically unsuitable for the study.
* Is incapable of understanding the language in which the information for the patient is given
* Participation in a concurrent clinical trial or in another trial with an investigational compound within the past 30 days;

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>A - Contrast enhancement scores:<br /><br>0. No enhancement: No contrast enhancement is detected within the target lesion<br /><br>1. Slight enhancement: Presence of minimal BR55 contrast enhancement in the<br /><br>target lesion<br /><br>2. Moderate enhancement: Presence of moderate BR55 contrast enhancement in the<br /><br>target lesion<br /><br>3. Strong enhancement: Presence of strong BR55 contrast enhancement in the<br /><br>target lesion.<br /><br><br /><br>B - Histopathology and Immunohistochemistry assessments</p><br>

Secondary Outcome Measures