Status:
TERMINATED
SonoVue Guided Prostate Biopsy
Lead Sponsor:
Bracco Diagnostics, Inc
Collaborating Sponsors:
Bracco Imaging S.p.A.
Conditions:
Prostate Cancer
Eligibility:
MALE
40+ years
Phase:
PHASE3
Brief Summary
This is a phase III European multicenter, open label, prospective study to assess the diagnostic accuracy of the use of SonoVue contrast agent to guide prostate biopsies in comparison with the current...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2011
Estimated Enrollment :
282 Patients enrolled
Trial Details
Trial ID
NCT00911027
Start Date
February 1 2009
End Date
March 1 2011
Last Update
April 25 2012
Active Locations (17)
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1
Medical University Innsbruck
Innsbruck, Austria, 6020
2
University Hospital K.U. Leuven
Leuven, Belgium, 3000
3
Hôpital Edouard Herriot
Lyon, France, 69437
4
Hôpital Necker-Enfants Malades
Paris, France, 75743