Multiparametric Ultrasound-Study for the Detection of Prostate Cancer

NCT03091231 | Completed

• 1 other identifier: mpUS-Study_2016
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

mpUS multiparametric Ultrasound DIAGNOSTIC_TEST

compare the mpUS to other methods

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: only men get prostate cancer
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• age ≥ 18 years
• signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Martini-Klinik am UKE GmbH: lead
• Eindhoven University of Technology: collaborator

Study Sites (1)

Martini-Klinik am UKE GmbH

Hamburg, 20246, Germany

Location

Related Publications (1)

• 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.

  PMID: 30409150 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Georg Salomon, PD Dr.

  Martini-Klinik am UKE GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 27, 2017
• Study Start: May 15, 2017
• Primary Completion: December 31, 2017
• Study Completion: March 31, 2018
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)