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

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Drug: SonoVue

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • AMC University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: H. Wijkstra, Prof. Dr. Ir., AMC University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: November 21, 2011
• First Submitted That Met QC Criteria: November 28, 2011
• First Posted (Estimate): November 29, 2011

Study Record Updates

• Last Update Posted (Estimate): July 6, 2016
• Last Update Submitted That Met QC Criteria: July 4, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Keywords: Prostate cancer; Microbubbles; Contrast Enhanced Ultrasound (CEUS); Quantification; Prostate biopsies; Transrectal ultrasound (TRUS)
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: NL37231.018.11