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

Not Applicable

Terminated

• Conditions: Prostate Cancer
• Interventions: Drug: SonoVue

• Registration Number: NCT01481441
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-21
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-29
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-04
• Last Update Posted: 2016-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 208

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SonoVue	SonoVue	Ultrasound Contrast Agent

Primary Outcome Measures

Name	Time	Method
Quantification prediction compared with prostate biopsy histology	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 Outcome Measures

Name	Time	Method
Quantification prediction compared with prostate biopsy histology	3 years	Prostate cancer Gleason score compared to quantification results; Answering the question: Is there a relation between Gleason score and quantification results?

Trial Locations

Locations (1)

AMC University Hospital; 🇳🇱 Amsterdam, Netherlands