Virtual Theranostic Trials: New Approach Methodologies (NAMs) and Precision Radiopharmaceutical Therapies

TL;DR

This paper proposes virtual theranostic trials that leverage quantitative imaging and patient-specific models to improve personalized radiopharmaceutical therapies, addressing current operational and biological challenges.

Contribution

Introduction of virtual theranostic trials as a novel approach to enhance evidence generation and personalization in radiopharmaceutical therapy development.

Findings

Virtual trials can accelerate therapy development.

They enable personalized treatment scheduling.

They help overcome operational constraints.

Abstract

Radiopharmaceutical therapies are expanding rapidly, but clinical evidence generation is limited by operational constraints and biological heterogeneity in radiopharmaceutical delivery and radiation risk. Virtual theranostic trials can run as companion trials, linking quantitative imaging to patient-specific models to generate evidence for personalized injections and scheduling, accelerate development, and broaden access.