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Brief Title: SonoVue Guided Prostate Biopsy
Official Title: A Phase III Study to Compare SonoVue Guided Prostate Biopsy With Systematic Biopsy in the Detection of Prostate Malignant Lesions in Patients With Suspected Prostate Cancer
Study ID: NCT00911027
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 practice of ultrasound guided systematic biopsy. The trial will involve 15-20 European Centers.
Detailed Description:
Minimum Age: 40 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Medical University Innsbruck, Innsbruck, , Austria
University Hospital K.U. Leuven, Leuven, , Belgium
Hôpital Edouard Herriot, Lyon, , France
Hôpital Necker-Enfants Malades, Paris, , France
CHRU Tours - Hôpital Bretonneau, Tours, , France
Institut für Radiologie der Charité, Berlin, , Germany
Martini-Klinik, Prostate Cancer Center, Hamburg, , Germany
Urologische Klinik und Poliklinik, Munich, , Germany
Orsola-Malpighi Hospital, Urology and Radiology Unit "Malpighi", Bologna, , Italy
Ospedale Valduce, Como, , Italy
European Institute of Oncology, Milan, , Italy
I.R.C.C.S. San Raffaele, Milan, , Italy
University of Palermo, Palermo, , Italy
University of Trieste, Trieste, , Italy
AMC University Amsterdam, Amsterdam, , Netherlands
Erasmus MC, Rotterdam, , Netherlands
Imperial College NHS Trust - Charing Cross, London, , United Kingdom
Name: Maria L Storto, MD
Affiliation: Bracco Diagnostics, Inc
Role: STUDY_CHAIR