EANM guidance document: dosimetry for first-in-human studies and early phase clinical trials.
Eur J Nucl Med Mol Imaging
; 51(5): 1268-1286, 2024 Apr.
Article
en En
| MEDLINE
| ID: mdl-38366197
ABSTRACT
The 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.
Palabras clave
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Radiofármacos
/
Medicina Nuclear
Límite:
Humans
Idioma:
En
Año:
2024
Tipo del documento:
Article