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

NCT ID: NCT01481441

Last Updated: 2016-07-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-11-30

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

SonoVue

Ultrasound Contrast Agent

Group Type: OTHER

SonoVue

Intervention Type: DRUG

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

Interventions

SonoVue

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

Intervention Type: DRUG

Other Intervention Names

SonoVue sulphur hexafluoride microbubbles 8 microlitres/ml; Powder and solvent for dispersion for injection.; MARKETING AUTHORISATION NUMBER(S): EU/1/01/177/002

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

Sponsor Role: lead

Responsible Party

Prof. dr. ir. H. Wijkstra

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

H. Wijkstra, Prof. Dr. Ir.

Role: PRINCIPAL_INVESTIGATOR

AMC University Hospital

Locations

AMC University Hospital

Amsterdam, , Netherlands

Countries

Netherlands

References

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.

Reference Type: RESULT

PMID: 25754526 (View on PubMed)

Other Identifiers

NL37231.018.11

Identifier Type: -

Identifier Source: org_study_id