Multiparametric Ultrasound-Study for the Detection of Prostate Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-15

Study Completion Date

2018-03-31

Brief Summary

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The primary objective of the study is the matching of sensitivity, specificity, the negative predicate value and the positive predictive value of Contrast-Enhanced Ultrasound (CEUS), Shear Wave Elastography (SWE) and the combination to detect clinically significant prostate carcinoma foki.

Conventional ultrasound is insufficient to safely display prostate carcinoma. Therefore, other imaging agents are recently added to improve the detection of tumor foci. These include innovative imaging ultrasound methods and multiparametric MRI.

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Detailed Description

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All patients scheduled for radical prostatectomy in the Martini-Klinik are admitted the day prior to the surgery. In case a patient gives his informed consent mpUS (multiparametric Ultrasound) scanning is performed on the day prior to surgery, the day of admittance. The patient will be prepared with an intravenous access to administer the contrast agent. Ultrasound Scanning will be performed in the left-lateral decubitus position and start with regular B-mode scanning and volumetry. A base to apex sweeps and left to right sweep will be acquired to allow building a 3D reconstruction of the prostate. The imaging protocol will then start with SWE. Stiffness of the tissue is measured in Shear modulus (kPa) and visualized in a color scale. SWE results will be recorded for later interpretation and analysis. Then 2 minute recordings of CEUS imaging will be made following the administration of a 2.4ml bolus of the contrast agent SonoVue® (Bracco, Geneva) through the intravenous canula. A maximum of four recordings will be made. For every recording a new bolus of contrast agent will be administered. In this way, for planes the contrast inflow can be recorded. Data will be stored and transported to an image processing system for dispersion analysis. On this system a dispersion (CUDI) parametric map will be constructed from each acquired CEUS recording. At the time of interpretation imaging results will be scored separately for the standard prostate sextants, base left, base right, mid left, mid right, apex left and apex right.

The radical prostatectomy will be performed as in accordance to institution standards. This procedure will not be altered because of the trial. In many cases this means frozen sections are taken intraoperatively from the lateral sides of the prostate. These frozen sections are processed separately from the resection specimen in the pathology lab. Following the radical prostatectomy the resection specimen is fixated according to institution standards. This means that the specimen is photographed and the location and orientation of all coupes is recorded. This will enable allocating pathology findings to the standard prostate sextants described earlier.

Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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mpUS multiparametric Ultrasound

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Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* age ≥ 18 years
* signed informed consent

Exclusion Criteria

* History of any clinically evidence of cardiac right-to-left shunts
* Receives treatment that includes dobutamine
* Severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No