Clinical trials with alpha emitters: promises and challenges
Description
This session will focus on the specific considerations involved in clinical trials of alpha-particle radiopharmaceutical therapies. Unlike beta emitters, alpha-emitter therapies bring unique characteristics, short particle range, high linear energy transfer, steep dose gradients, and distinct radiobiology, that affect dosimetry approaches, safety monitoring, and trial logistics. The first part of the session will outline the underlying physical and biological differences that drive these deviations, clarifying why beta trial frameworks cannot be directly transplanted. The second part will discuss how these properties impact trial design, regulatory pathways, patient selection, and dosimetry requirements. The third talk will present a case study on alpha DaRT clinical trials, illustrating how these concepts play out in real-world implementation, including how dose prescription, QA, and safety evaluation differ from conventional RPT trials.