Mannaerts, Christophe K. http://orcid.org/0000-0002-3824-5631
Wildeboer, Rogier R.
Postema, Arnoud W.
Hagemann, Johanna
Budäus, Lars
Tilki, Derya
Mischi, Massimo
Wijkstra, Hessel
Salomon, Georg
Funding for this research was provided by:
KWF Kankerbestrijding (UVA 2013-5941)
Article History
Received: 13 March 2018
Accepted: 17 October 2018
First Online: 8 November 2018
Ethics approval and consent to participate
: This trial will be conducted in accordance to the Good Clinical Practice standards, with the ethical principles that have their origins in the Declaration of Helsinki (Fortealiza, Brazil, October 2013). The trial protocol has been reviewed and approved by the IRB of the University Hospital Hamburg-Eppendorf (Ethik-Kommission der Ärztekammer Hamburg), Germany under study ID: PV5439 on February 13, 2017 and prospectively registered on theExternalRef removeddatabase (NCT03091231) on March 14, 2017. Any amendments to the trial protocol will be submitted for review by the IRB. Trial registrations will be updated and participants will be informed about the risks and benefits of participation both verbally by one of the investigators and in writing in the form of an extensive patient information brochure. Participants will only be included after written informed consent has been obtained by the medical doctor performing the multiparametric ultrasound imaging. Patients can leave the study at any time for any reason if they wish to do so without any consequences. The investigator can decide to withdraw a subject from the study for urgent (medical) reasons. Patient data will be anonymized and stored in a secure database.
: Not applicable
: All authors of this manuscript declare no relationships with any companies, products or services related to the matter of the study.
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