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Multiparametric Ultrasound-Study for the Detection of Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03091231
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
Eindhoven University of Technology
Information provided by (Responsible Party):
Martini-Klinik am UKE GmbH

Brief Summary:

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.


Condition or disease Intervention/treatment
Prostate Cancer 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.

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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multiparametric Ultrasound - Contrast Enhanced Ultrasound and Shear Wave Elastography Compared to Radical Prostatectomy Specimens in 50 Patients
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : March 31, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: mpUS multiparametric Ultrasound
    compare the mpUS to other methods


Primary Outcome Measures :
  1. Diagnostic accuracy in terms of sensitivity and specificity of CEUS, SWE and their combination using radical prostatectomy specimens as the gold-standard. [ Time Frame: 14 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   only men get prostate cancer
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091231


Locations
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Germany
Martini-Klinik am UKE GmbH
Hamburg, Germany, 20246
Sponsors and Collaborators
Martini-Klinik am UKE GmbH
Eindhoven University of Technology
Investigators
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Principal Investigator: Georg Salomon, PD Dr. Martini-Klinik am UKE GmbH

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: mpUS2016
to request an electronic copy send an email to a.renter@uke.de

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Martini-Klinik am UKE GmbH
ClinicalTrials.gov Identifier: NCT03091231    
Other Study ID Numbers: mpUS-Study_2016
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized data from ultrasound results and histological findings are sent to the TU Eindhoven in Eindhoven (Netherlands) for quantification analysis.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases