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

NCT01481441 | Terminated

• 1 other identifier: NL37231.018.11
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Quantification prediction compared with prostate biopsy histology

  3 years

Study Arms (1)

SonoVue

OTHER

Ultrasound Contrast Agent

Drug: SonoVue

Interventions

SonoVue DRUG

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

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

SonoVue

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• age ≥ 18 years
• signed informed consent
• 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.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

AMC University Hospital

Amsterdam, 1105 AZ, Netherlands

Location

Related 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 Jun 29.

  PMID: 25754526 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

contrast agent BR1; Powders; Solvents; Injections

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Specialty Uses of Chemicals; Chemical Actions and Uses; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• H. Wijkstra, Prof. Dr. Ir.

  AMC University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2011
• First Posted: November 29, 2011
• Study Start: November 1, 2011
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

NL (1)