Multiparametric Ultrasound-Study for the Detection of Prostate Cancer

Multiparametric Ultrasound - Contrast Enhanced Ultrasound and Shear Wave Elastography Compared to Radical Prostatectomy Specimens in 50 Patients

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: mpUS multiparametric Ultrasound

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Martini-Klinik am UKE GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

All patients scheduled for radical prostatectomy in the Martini Klinik that fulfil the inclusion criteria and do not have any of the exclusion criteria are eligible for participation in this study. Patients will be informed about the objectives, procedures and risks of the study all patients will have to sign written informed consent prior to participation.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy in terms of sensitivity and specificity of CEUS, SWE and their combination using radical prostatectomy specimens as the gold-standard.	The data gathered will be structured so that for each prostate sextant B-mode TRUS results, SWE results, CEUS results including CUDI maps and Pathology results are available for correlation. For the imaging modalities quantifiable data and visual interpretation using a 1 to 5 Likert-type scale for suspicion will be stored for each sextant. Pathology data will be gathered in the form of tumor size and grade. The data will be used to calculate sensitivity, specificity, negative predictive value and positive predictive value for each of the imaging modalities separately. Furthermore the data will be used to calculate an optimal algorithm for combining the imaging modalities. The maximum attainable sensitivity, specificity, NPV and PPV for tumor detection using this optimized algorithm will be calculated.	14 days

Collaborators and Investigators

• Sponsor: Martini-Klinik am UKE GmbH
• Collaborators: Eindhoven University of Technology
• Investigators: Principal Investigator: Georg Salomon, PD Dr., Martini-Klinik am UKE GmbH

Publications and helpful links

General Publications

• Mannaerts CK, Wildeboer RR, Postema AW, Hagemann J, Budaus L, Tilki D, Mischi M, Wijkstra H, Salomon G. Multiparametric ultrasound: evaluation of greyscale, shear wave elastography and contrast-enhanced ultrasound for prostate cancer detection and localization in correlation to radical prostatectomy specimens. BMC Urol. 2018 Nov 8;18(1):98. doi: 10.1186/s12894-018-0409-5.

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): March 31, 2018

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 27, 2017

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: mpUS-Study_2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Anonymized data from ultrasound results and histological findings are sent to the TU Eindhoven in Eindhoven (Netherlands) for quantification analysis.

Study Data/Documents

1. Study Protocol
   Information identifier: mpUS2016
   Information comments: to request an electronic copy send an email to a.renter@uke.de

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No