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  1. Home
  3. Pathways And Challenges In The Clinical Translational Of Radiopharmaceuticals For Pediatric Investigations.
  1. Home
  3. Pathways And Challenges In The Clinical Translational Of Radiopharmaceuticals For Pediatric Investigations.

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Pathways and challenges in the clinical translational of radiopharmaceuticals for pediatric investigations.

Erik Stauff1,2, Hanieh Karimi1,2, Heidi H Kecskemethy1,2

  • 1Department of Radiology, Nemours Children's Health, Wilmington, DE, United States.

Frontiers in Medicine
|November 24, 2025

View abstract on PubMed

Summary
This summary is machine-generated.

Developing radiopharmaceuticals for children faces regulatory hurdles. Innovations in molecular imaging offer promise but require updated frameworks for safe pediatric use and equitable access.

Keywords:
FDA guidelinesclinical trialmolecular imagingpediatric radiopharmaceuticalsregulatory pathways

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Area of Science:

  • Medical Imaging
  • Radiopharmaceutical Science
  • Pediatric Research

Background:

  • Molecular imaging shows promise for pediatric diseases like neuroblastoma and autism spectrum disorders.
  • Current regulatory pathways (IND, eIND, RDRC) are not optimized for pediatric radiotracer translation.
  • Children's unique sensitivities and ethical considerations complicate clinical trials.

Purpose of the Study:

  • To identify challenges in pediatric radiopharmaceutical development and clinical translation.
  • To evaluate existing regulatory frameworks for pediatric molecular imaging.
  • To explore how emerging technologies can address pediatric-specific needs.

Main Methods:

  • Review of existing regulatory pathways for radiotracer approval (FDA IND, eIND, RDRC).
  • Analysis of challenges in pediatric clinical trial design, including radiation sensitivity, dosimetry, and ethics.
  • Examination of emerging molecular imaging technologies and their potential impact on pediatric applications.

Main Results:

  • Existing regulatory frameworks present significant barriers to pediatric radiopharmaceutical translation.
  • Pediatric-specific factors like radiation sensitivity and physiological variability complicate trial design and dosing.
  • Emerging technologies offer potential solutions but require further development for pediatric use.

Conclusions:

  • Updated regulatory guidance and ethical frameworks are crucial for pediatric molecular imaging.
  • Addressing inconsistent dosing standards and ensuring equitable access to innovations is essential.
  • A concerted effort is needed to bridge the gap between radiotracer innovation and safe pediatric application.