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SonoVue Guided Prostate Biopsy

NCT00911027 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 282

Last updated 2012-04-25

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Bracco Imaging S.p.A.

    collaborator INDUSTRY

  • Bracco Diagnostics, Inc

    lead INDUSTRY

Principal Investigators

  • Maria L Storto, MD · Bracco Diagnostics, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-03-31
Completion
2011-03-31

Countries

  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00911027 on ClinicalTrials.gov