Ken Herrmann | Theragnostic Imaging

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

Mon, 01 Apr 2024 00:00:00 +0000

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.

Correction to: EANM enabling guide: how to improve the accessibility of clinical dosimetry

Tue, 01 Aug 2023 00:00:00 +0000

No abstract available

EANM enabling guide: how to improve the accessibility of clinical dosimetry

Thu, 01 Jun 2023 00:00:00 +0000

Dosimetry can be a useful tool for personalization of molecular radiotherapy (MRT) procedures, enabling the continuous development of theranostic concepts. However, the additional resource requirements are often seen as a barrier to implementation. This guide discusses the requirements for dosimetry and demonstrates how a dosimetry regimen can be tailored to the available facilities of a centre. The aim is to help centres wishing to initiate a dosimetry service but may not have the experience or resources of some of the more established therapy and dosimetry centres. The multidisciplinary approach and different personnel requirements are discussed and key equipment reviewed example protocols demonstrating these factors are given in the supplementary material for the main therapies carried out in nuclear medicine, including [¹³¹I]-NaI for benign thyroid disorders, [¹⁷⁷Lu]-DOTATATE and ¹³¹I-mIBG for neuroendocrine tumours and [⁹⁰Y]-microspheres for unresectable hepatic carcinoma.