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

Primary Purpose

Prostate Cancer

Status
Terminated
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
SonoVue
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring Contrast Enhanced Ultrasound (CEUS), Prostate cancer, Quantification, Prostate biopsies, Transrectal ultrasound (TRUS), Microbubbles

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • AMC University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SonoVue

Arm Description

Ultrasound Contrast Agent

Outcomes

Primary Outcome Measures

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?

Secondary Outcome Measures

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?

Full Information

First Posted
November 21, 2011
Last Updated
July 4, 2016
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT01481441
Brief Title
Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer
Acronym
AMC_2011_190
Official Title
Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
New study protocol started including targeted biopsies
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Contrast Enhanced Ultrasound (CEUS), Prostate cancer, Quantification, Prostate biopsies, Transrectal ultrasound (TRUS), Microbubbles

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SonoVue
Arm Type
Other
Arm Description
Ultrasound Contrast Agent
Intervention Type
Drug
Intervention Name(s)
SonoVue
Other Intervention Name(s)
SonoVue sulphur hexafluoride microbubbles 8 microlitres/ml, Powder and solvent for dispersion for injection., MARKETING AUTHORISATION NUMBER(S): EU/1/01/177/002
Intervention Description
2.4 ml Bolus Injection by intravenous canule. Multi-repeatable (up to 4 bolus) if necessary.
Primary Outcome Measure Information:
Title
Quantification prediction compared with prostate biopsy histology
Description
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?
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Quantification prediction compared with prostate biopsy histology
Description
Prostate cancer Gleason score compared to quantification results Answering the question: Is there a relation between Gleason score and quantification results?
Time Frame
3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
H. Wijkstra, Prof. Dr. Ir.
Organizational Affiliation
AMC University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AMC University Hospital
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
25754526
Citation
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.
Results Reference
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Quantification of Contrast Enhanced Ultrasound (CEUS) in the Detection of Prostate Cancer

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