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Clinical Trials/NCT01481441
NCT01481441
Terminated
Not Applicable

Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 site in 1 country208 target enrollmentNovember 2011
ConditionsProstate Cancer
InterventionsSonoVue
DrugsSonoVue

Overview

Phase
Not Applicable
Intervention
SonoVue
Conditions
Prostate Cancer
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Enrollment
208
Locations
1
Primary Endpoint
Quantification prediction compared with prostate biopsy histology
Status
Terminated
Last Updated
9 years ago

Overview

Brief Summary

With Contrast Enhanced UltraSound (CEUS) cancer induced neovascularisation can be visualised with the potential to improve ultrasound imaging for prostate cancer detection and localisation significantly. The past years numerous studies have been performed with CEUS, all basing their results on subjective judgement of the investigator. CEUS image interpretation is difficult and requires a well-trained expert. To overcome these difficulties CEUS quantification techniques can be of use. The techniques used in this protocol have been developed in cooperation with the Technical University in Eindhoven (TU/e) and BRACCO, Geneva.

The investigators hypothesize improvement of the PCa detection rate with quantification, compared with subjective CEUS interpretation and known numbers in literature.

Also a comparison between quantification results and tumour differentiation grade (Gleason score) will be made, the investigators hypothesize a positive correlation.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
November 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Prof. dr. ir. H. Wijkstra

Principal Investigator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

SonoVue

Ultrasound Contrast Agent

Intervention: SonoVue

Outcomes

Primary Outcomes

Quantification prediction compared with prostate biopsy histology

Time Frame: 3 years

Prostate cancer detection rate by quantification. Answering the question: What is the difference in, for malignancy suspicious, areas between CEUS quantification and subjective interpretation in relation to the histological biopsy results?

Secondary Outcomes

  • Quantification prediction compared with prostate biopsy histology(3 years)

Study Sites (1)

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