Prostate Cancer Clinical Trial
— AMC_2011_190Official title:
Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer
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.
Status | Terminated |
Enrollment | 208 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Netherlands | AMC University Hospital | Amsterdam |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Quantification prediction compared with prostate biopsy histology | 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? |
3 years | Yes |
Secondary | Quantification prediction compared with prostate biopsy histology | Prostate cancer Gleason score compared to quantification results Answering the question: Is there a relation between Gleason score and quantification results? |
3 years | Yes |
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