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Whole-body PET/MRI of Pediatric Patients: The Details That Matter
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Paediatric development of radiopharmaceutical imaging agents and radioligand therapeutics

Justin L Hay1, Amandine Manon1, Hunter Stephens1

  • 1Certara, Radnor, Pennsylvania, USA.

British Journal of Clinical Pharmacology
|December 21, 2025
PubMed

Insights

This review explores radiopharmaceuticals for children, covering diagnostic agents and therapeutics. It highlights challenges and regulatory pathways for developing these crucial nuclear medicine tools for pediatric use.

Area of Science:

  • Nuclear medicine
  • Radiopharmaceutical development
  • Pediatric oncology

Background:

  • Nuclear medicine is vital for diagnosing and treating childhood cancers, infections, and brain disorders.
  • It offers functional and structural insights for early, specific diagnoses in children with nonspecific symptoms.
  • Radiopharmaceuticals aid in assessing organ function, crucial for pediatric patient care.

Purpose of the Study:

  • To review the development of radiopharmaceutical imaging agents and radioligand therapeutics for pediatric use.
  • To discuss the current landscape, challenges, and regulatory pathways for pediatric radiopharmaceuticals.
  • To highlight the importance of dose optimization and innovative trial designs.

Main Methods:

  • Literature review of current radiopharmaceutical agents and therapies in pediatric clinical development.
  • Analysis of challenges including ethical considerations, physiological differences, data limitations, and regulatory hurdles.
  • Examination of dose determination approaches, clinical considerations, and regulatory pathways (FDA, EMA, RACE Act, PIPs, iPSPs).

Main Results:

  • The review covers existing and developing diagnostic imaging agents and radioligand therapies for pediatric applications.
  • Key challenges in pediatric radiopharmaceutical development include ethical issues, tailored dosing, limited data, and regulatory complexities.
  • Current approaches for dose determination and regulatory pathways are discussed, emphasizing the need for optimization.

Conclusions:

  • Developing safe and effective radiopharmaceuticals for children requires addressing unique challenges and navigating specific regulatory frameworks.
  • Optimizing dosage and employing innovative clinical trial designs are essential for advancing pediatric nuclear medicine.
  • Continued research and collaboration are crucial for improving diagnostic and therapeutic radiopharmaceutical options for pediatric patients.

Keywords:
clinical developmentdrug developmentmodel‐based drug developmentpaediatricsradiotherapeutics

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