EANM guidance document: dosimetry for first-in-human studies and early phase clinical trials

• DOI: 10.1007/s00259-024-06640-x
• Publication Date: 2024-02-17T03:02:06Z
• Authors: Caroline Stokke; Silvano Gnesin; Johannes Tran-Gia; Francesco Cicone; Søren Holm; Marta Cremonesi; Johan Blakkisrud; Thomas Wendler; Nic Gillings; Ken Herrmann; Felix M. Mottaghy; Jonathan Gear
• Keywords: ddc:610; Dosimetry; First-in-human; Nuclear medicine; Medizin; Humans; Radiopharmaceuticals/therapeutic use; Radiometry/methods; Radionuclide Imaging; Nuclear Medicine/methods; Dosimetry; European Association of Nuclear Medicine; First-in-human; Nuclear medicine; Radiopharmaceuticals; European Association of Nuclear Medicine; Humans; Guidelines; Radiopharmaceuticals; Nuclear Medicine; Radiometry; Radionuclide Imaging

AbstractThe numbers of diagnostic and therapeutic nuclear medicine agents under investigation are rapidly increasing. Both novel emitters and novel carrier molecules require careful selection of measurement procedures. This document provides guidance relevant to dosimetry for first-in human and early phase clinical trials of such novel agents. The guideline includes a short introduction to different emitters and carrier molecules, followed by recommendations on the methods for activity measurement, pharmacokinetic analyses, as well as absorbed dose calculations and uncertainty analyses. The optimal use of preclinical information and studies involving diagnostic analogues is discussed. Good practice reporting is emphasised, and relevant dosimetry parameters and method descriptions to be included are listed. Three examples of first-in-human dosimetry studies, both for diagnostic tracers and radionuclide therapies, are given.