Trials / Terminated
TerminatedNCT00911027
SonoVue Guided Prostate Biopsy
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
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 282 (actual)
- Sponsor
- Bracco Diagnostics, Inc · Industry
- Sex
- Male
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Contrast-enhanced ultrasound guided biopsy | One to two bolus (each 2.4mL) of SonoVue per patient in the optimization part One to four bolus (each 2.4mL) of SonoVue per patient in the main part |
| PROCEDURE | ultrasound guided systematic biopsy | Current practice of ultrasound guided systematic biopsy |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2011-03-01
- Completion
- 2011-03-01
- First posted
- 2009-06-01
- Last updated
- 2012-04-25
Locations
17 sites across 7 countries: Austria, Belgium, France, Germany, Italy, Netherlands, United Kingdom
Source: ClinicalTrials.gov record NCT00911027. Inclusion in this directory is not an endorsement.