Thivat, Emilie
Casile, Mélanie
Moreau, Juliette
Molnar, Ioana
Dufort, Sandrine
Seddik, Khalide
Le Duc, Géraldine
De Beaumont, Olivier
Loeffler, Markus
Durando, Xavier
Biau, Julian
Article History
Received: 31 March 2023
Accepted: 8 April 2023
First Online: 15 April 2023
Declarations
:
: The study protocol and its amendments obtained approval from the French Ethics Committee (Comité de protection des personnes Ile de France X) (ref 20.12.01.45646) in February 2021 and from the French National Agency for the Safety of Medicines and Health Products (ANSM) (N°Eudra CT 2020–004552-15) in January 2021.The study is conducted in accordance with the Helsinki Declaration, the Good Clinical Practice (GCP) guidelines of the International Conference on Harmonisation (ICH–E6, 17/07/96), General Data Protection Regulation (GDPR) and local regulatory requirements. Written informed consent will be obtained from each patient by the investigator before any study-related assessment starts.
: Not applicable.
: GLD discloses patent No. WO2009/053644 which protects the AGuIX nanoparticles described in this publication. SD, KS, ML, ODB and GLD are employees of NH TherAguix (Meylan, France), which is developing the AGuIX nanoparticles. SD, ML and GLD own shares in this company. The other authors declare that they have no competing interests.