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

Prostate Cancer Clinical Trial

— AMC_2011_190  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01481441
• Other study ID #: NL37231.018.11
• Status: Terminated
• Phase: N/A
• First received: November 21, 2011
• Last updated: July 4, 2016
• Start date: November 2011
• Est. completion date: November 2015

Study information

• Verified date: July 2016
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Netherlands	AMC University Hospital	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

References & Publications (1)

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

Outcome

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