Forster, Tobias
Jäkel, Cornelia
Akbaba, Sati
Krug, David
Krempien, Robert
Uhl, Matthias
Häfner, Matthias Felix
König, Laila
Koerber, Stefan Alexander
Harrabi, Semi
Bernhardt, Denise
Behnisch, Rouven
Krisam, Johannes
Hennigs, Andre
Sohn, Christof
Heil, Jörg
Debus, Jürgen
Hörner-Rieber, Juliane
Funding for this research was provided by:
IntraOp Medical
Article History
Received: 6 March 2020
Accepted: 20 May 2020
First Online: 1 June 2020
Ethics approval and consent to participate
: The final study protocol was approved by the ethics committee of the Medical Faculty of Heidelberg University (S-826/2018). In the clinical study, no ionizing radiation in humans for the purpose of medical research will be used, since all treatments within this protocol are clinically indicated and performed within the medical responsibility of the participating centers and only clinically established therapies and diagnostics are used. Therefore, concerning radiation protection law (StrSchV), the authors of this protocol presume that a submission to the Bundesamt für Strahlenschutz (BfS) is not required. To confirm this position, the investigators submitted this protocol to the expert commission of the German Society of Radiation Oncology (DEGRO). This study complies with the Helsinki Declaration and its recent German version, the Medical Association code of conduct, the principles of Good Clinical Practice (GCP) and the Federal Data Protection Act. The trial will be carried out in keeping with local legal and regulatory requirements. Each patient must provide written informed consent for participation in the study and for publication before enrollment.
: Not applicable.
: This trial is financially supported by IntraOP Medical, 570 Del Rey Avenue, Sunnyvale, CA 94085. IntraOP Medical is not involved in the design of the study, nor the collection, storage or analysis of the data gathered in this study. All authors declare that there is no conflict of interest in connection with the implementation and evaluation of this study.