Chiesa, C. http://orcid.org/0000-0003-0634-013X
Mira, M.
Bhoori, S.
Bormolini, G.
Maccauro, M.
Spreafico, C.
Cascella, T.
Cavallo, A.
De Nile, M. C.
Mazzaglia, S.
Capozza, A.
Tagliabue, G.
Brusa, A.
Marchianò, A.
Seregni, E.
Mazzaferro, V.
Funding for this research was provided by:
BTG biocompatibles (SPETc-DOSE-1)
Article History
Received: 1 December 2019
Accepted: 28 April 2020
First Online: 25 May 2020
Compliance to ethical standards
:
: Carlo Chiesa received honoraria for consultancies from BTG Biocompatibles and Terumo. He also received a research grant from BTG Biocompatibles for this Investigator Initiated Study.Marta Mira received a 15-month research grant from BTG Biocompatibles in order to perform this study.Marco Maccauro, Carlo Spreafico, Sherrie Bhoori and Vincenzo Mazzaferro received honoraria as consultant and speakers from BTG Biocompatibles.All the other authors have nothing to disclose.
: The present Investigator Initiated Study (SPETc-DOSE-1) and the grant from BTG Biocompatibles were approved by the Ethics Committee and by the legal office of our Institution Fondazione IRCCS Istituto Nazionale Tumori (Committee for Trials on New Diagnostic and Therapeutic Methods—Comitato per la Sperimentazione dei Nuovi Metodi Diagnostici e Terapeutici, protocol number INT/99/17 Q/17/063). Our research has been performed in accordance with the ethical standards as cited in the 1964 Declaration of Helsinki.Informed consent, for Cohort 3 thoroughly explaining the dosimetric optimization of treatment, was obtained from all patients before the <sup>99m</sup>Tc-MAA angioscintigraphic session (simulation). For Cohort 1, informed consent for the whole radioembolization procedure according to TheraSphere indication was obtained from all patients within the prospective phase II study [CitationRef removed].Consent to retrospective clinical data collection was conducted according to the Italian legislation valid during the study. The corresponding author and P.I. of the study, Carlo Chiesa, signed a declaration stating that patients were not reachable at the time of the study since they died before the beginning of data collection.