Bentestuen, Morten http://orcid.org/0000-0001-6115-0967
Ladekarl, Morten http://orcid.org/0000-0002-0182-1228
Knudsen, Aage
Zacho, Helle D. http://orcid.org/0000-0001-9089-288X
Funding for this research was provided by:
Alfred Benzon Foundation
The North Jutland Health Science Research Foundation, Denmark
Article History
Received: 29 January 2024
Accepted: 31 May 2024
First Online: 7 June 2024
Declarations
:
: The study was approved by the Danish Medical research committee no. 2. Informed consent will be obtained from all the study participants. [<sup>68</sup>Ga]Ga-FAPI-46 is not authorized for marketing or clinical use by the Danish Medicines Agency, the European Medicines Agency (EMA), or the United States Food and Drug Administration (FDA). Prior to recruitment, [<sup>68</sup>Ga]Ga-FAPI-46 was uploaded to the extended Eudravigilance medicinal product dictionary (XEVMPD), and investigational medicinal product dossier (IMPD) for the quality of the final synthesized radiopharmaceutical and for safety and efficacy were produced. Given that there are no known side effects associated with [<sup>68</sup>Ga]Ga-FAPI-46, all side effects will be considered unexpected, and all serious adverse reactions (SARs) will be considered suspected unexpected SARs (SUSARs) and will be reported in the EudraVigilance database. An annual safety report (ASR) will be submitted through the European Clinical Trial Information System (EU CTIS), and the study will be fully Good Clinical Practice (GCP) monitored by an independent GCP unit. The study is conducted in compliance with national laws, with EU regulation 2014/536 on clinical trials on medicinal products, a committee on medicinal health research ethics, informed consent regulations, the Declaration of Helsinki, and GCP guidelines. The data will be stored and handled in accordance with GCP guidelines, The Danish Personal Data Protection Act (“Databeskyttelsesloven”, No 502 of 23.05.2018), and the European General Data Protection Regulation (GDPR) (EU regulation 2016/679) [, ]. Eligible patients will be given oral and written information about the trial by the study-trained staff from the collaborating department or investigator/sponsor. Participation in the study is entirely voluntary and consent can be withdrawn at any time. If the patient declines participation or withdraws consent, this will not have any consequences or lack of opportunities for any other treatment. No remuneration will be paid to the patients for participation. No new research examinations of biological samples will be carried out without the permission of the Danish Research Ethics Committee.
: Not applicable.
: Currently recruiting (start of recruitment December 2023). Estimated end of recruitment: December 2025.
: M.L. received an unrestricted research grant from Scandion Oncology A/S, Denmark. All the other authors declare that they have no competing interests.