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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01481441

Acronym

AMC_2011_190

Enrollment

208

Registered

2011-11-29

Start date

2011-11-30

Completion date

2015-11-30

Last updated

2016-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Contrast Enhanced Ultrasound (CEUS), Prostate cancer, Quantification, Prostate biopsies, Transrectal ultrasound (TRUS), Microbubbles

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.

Interventions

DRUGSonoVue

2.4 ml Bolus Injection by intravenous canule. Multi-repeatable (up to 4 bolus) if necessary.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Population: All patients already scheduled for biopsy because of a raised Prostate-Specific Antigen (PSA) and/ or abnormal Digital Rectal Examination (DRE) in the Academic Medical Centre (AMC), excluding patients who do meet the

Exclusion criteria

. Inclusion criteria: * age ≥ 18 years * signed informed consent

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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?

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026