Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer (AMC_2011_190)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2011 by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor:
Information provided by (Responsible Party):
Prof. dr. ir. H. Wijkstra, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT01481441
First received: November 21, 2011
Last updated: November 30, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention
Prostate Cancer
Drug: SonoVue

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Quantification prediction compared with prostate biopsy histology [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    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?



Secondary Outcome Measures:
  • Quantification prediction compared with prostate biopsy histology [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    Prostate cancer Gleason score compared to quantification results

    Answering the question: Is there a relation between Gleason score and quantification results?



Estimated Enrollment: 560
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SonoVue
Ultrasound Contrast Agent
Drug: SonoVue
2.4 ml Bolus Injection by intravenous canule. Multi-repeatable (up to 4 bolus) if necessary.
Other 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01481441

Locations
Netherlands
AMC University Hospital Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: H. Wijkstra, Prof.Dr.Ir.    +31 20 5666379    h.wijkstra@amc.uva.nl   
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: H. Wijkstra, Prof. Dr. Ir. AMC University Hospital
  More Information

No publications provided

Responsible Party: Prof. dr. ir. H. Wijkstra, Principal Investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01481441     History of Changes
Other Study ID Numbers: NL37231.018.11
Study First Received: November 21, 2011
Last Updated: November 30, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Contrast Enhanced Ultrasound (CEUS)
Prostate cancer
Quantification
Prostate biopsies
Transrectal ultrasound (TRUS)
Microbubbles

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014