Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

This review focuses on the development of radiopharmaceutical imaging agents and radioligand therapeutics for paediatric use. Nuclear medicine plays an important role in the diagnosis and treatment of various childhood conditions, including cancers, infections and brain disorders. It assesses organ function alongside structure, allowing for earlier and more specific diagnoses, crucial in children where symptoms can be nonspecific. This review discusses the current landscape of paediatric radiopharmaceuticals, including commonly used diagnostic imaging agents and radioligand therapies, as well as drug candidates in clinical development. However, developing radiopharmaceuticals for children presents several challenges. These include ethical considerations, the need for tailored dosing and formulations due to physiological differences between children and adults, limited availability of paediatric-specific data and regulatory hurdles. The article provides an overview of current approaches for paediatric dose determination, including the use of consensus guidelines and ongoing efforts to refine dosimetry models. The review further addresses clinical considerations and regulatory pathways for paediatric radiopharmaceuticals, including the roles of the Food and Drug Administration (FDA) and European Medicines Agency (EMA), as well as specific legislation like the RACE Act in the United States. Finally, regulatory pathways for paediatric radiopharmaceuticals, including the role of paediatric investigation plans (PIPs) and initial paediatric study plans (iPSPs), are discussed. The importance of dose optimization and innovative clinical trial designs to advance the development of safe and effective radiopharmaceuticals for children is highlighted.