REVIEW article
Front. Med.
Sec. Nuclear Medicine
This article is part of the Research TopicExpert Opinions & Viewpoints in Nuclear MedicineView all articles
Pathways and Challenges in the Clinical Translational of Radiopharmaceuticals for Pediatric Investigations
Provisionally accepted
- 1Nemours Children’s Health, Delaware, Wilmington, United States
- 2The Hospital for Sick Children, Toronto, Canada
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Radiopharmaceutical development and clinical translation face numerous scientific, ethical, and regulatory challenges, particularly within the pediatric population. Although molecular imaging holds significant promise for improving diagnosis and treatment across a spectrum of diseases, including pediatric-specific conditions like Kawasaki disease, autism spectrum disorders, attention-deficit/hyperactivity disorder, and neuroblastoma, the path from discovery to clinical application remains problematic. The U.S. Food and Drug Administration (FDA) provides three primary pathways—traditional Investigational New Drug (IND) applications, exploratory Investigational New Drug application (eIND), and the Radioactive Drug Research Committee (RDRC) mechanism—to facilitate clinical translation of radiotracers. However, these frameworks are not specifically tailored to pediatric needs. Children's heightened sensitivity to ionizing radiation, coupled with physiological variability and ethical concerns, complicates trial design, dosimetry, and informed consent. Current practices also exhibit the limitation of inconsistent dosing standards across institutions. Emerging technologies—including improved single-photon emission computed tomography and positron emission tomography techniques, theranostics, whole-body scanners, and artificial intelligence-driven radiomics—offer potential to reduce these risks by enabling lower doses, reduced scan time, and more precise targeting. Nonetheless, a significant gap remains in translating these innovations into safe, equitable access for pediatric patients. Addressing these challenges requires updated regulatory guidance, ethical frameworks, and robust clinical strategies to ensure equitable access to molecular imaging innovations for children.
Keywords: pediatric radiopharmaceuticals, FDA guidelines, regulatory pathways, Molecular Imaging, Clinical Trial
Received: 02 Jul 2025; Accepted: 24 Oct 2025.
Copyright: © 2025 Stauff, Karimi, Kecskemethy, Shaffer, Vali, Averill and Yue. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Xuyi Yue, xuyi.yue@nemours.org
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