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


N/A
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Quantification prediction compared with prostate biopsy histology

Outcome 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?

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

H. Wijkstra, Prof. Dr. Ir.

Investigator Role:

Principal Investigator

Investigator Affiliation:

AMC University Hospital

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

NL37231.018.11

NCT ID:

NCT01481441

Start Date:

November 2011

Completion Date:

November 2015

Related Keywords:

  • Prostate Cancer
  • Contrast Enhanced Ultrasound (CEUS)
  • Prostate cancer
  • Quantification
  • Prostate biopsies
  • Transrectal ultrasound (TRUS)
  • Microbubbles
  • Prostatic Neoplasms

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