Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bracco Diagnostics, Inc
With
Bracco Imaging S.p.A.
Age
40–any
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Male patient, age ≥ 40 years old
Optimization part only: Diagnosis of prostate cancer
Main part: Suspected prostate cancer scheduled for first biopsy and tPSA ≤ 10 ng/mL OR already submitted to one systematic bioptic procedure with negative results currently under follow up procedure due to a persistent indication.
Written Informed Consent and willing to comply with protocol requirements
You may not be if
Documented acute prostatitis or urinary tract infections
Known allergy to sulphur hexafluoride micro bubbles
Any clinically unstable cardiac condition within 7 days prior to SonoVue® administration such as:
evolving or ongoing myocardial infarction
typical angina at rest within the previous 7 days
significant worsening of cardiac symptoms within the previous 7 days
recent coronary artery intervention or other factors suggesting clinical instability (e.g., recent deterioration of ECG, laboratory or clinical findings)
acute cardiac failure, class III/IV cardiac failure
severe cardiac rhythm disorders
right-to-left shunts
Severe pulmonary hypertension or uncontrolled systemic hypertension or respiratory distress syndrome
Bioptic procedure within 30 days before admission into this study (this exclusion criterion is only for the main part of the study)
Determined by the Investigator that the patient is clinically unsuitable for the study
Participation in a concurrent clinical trial or in another trial within the past 30 days
Repeated participation in this trial (the patient should not be enrolled twice in the present study)
