Clinical trial NCT01481441: Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer
Official title: Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Contrast Enhanced Ultrasound (CEUS)
Prostate cancer
Quantification
Prostate biopsies
Transrectal ultrasound (TRUS)
Microbubbles
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 208
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility 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

Exclusion criteria:

* Has documented acute prostatitis or urinary tract infections.
* History of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to-left shunts.
* Has had severe cardiac rhythm disorders within the last 7 days.
* Has severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
* Has received a biopsy procedure within 30 days before admission into this study
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study.
* Is incapable of understanding the language in which the information for the patient is given.

Primary outcomes:
measure: Quantification prediction compared with prostate biopsy histology
timeFrame: 3 years
Secondary outcomes:
measure: Quantification prediction compared with prostate biopsy histology
timeFrame: 3 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: AMC University Hospital
Study officials:
affiliation: AMC University Hospital
name: H. Wijkstra, Prof. Dr. Ir.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Postema AW, Frinking PJ, Smeenge M, De Reijke TM, De la Rosette JJ, Tranquart F, Wijkstra H. Dynamic contrast-enhanced ultrasound parametric imaging for the detection of prostate cancer. BJU Int. 2016 Apr;117(4):598-603. doi: 10.1111/bju.13116. Epub 2015 Jun 29.