Dosimetry in Clinical Trials

Targeted Radionuclide Therapy (TRT) is an expanding field of cancer treatment in which radiopharmaceuticals—comprising a radionuclide linked to a tumour-targeting biological vector—are administered to deliver cytotoxic radiation doses selectively to malignant tissues. The growing development of theragnostic agents, enabling both imaging and therapy, has strengthened the rationale for a patient-specific treatment approach.

In clinical trials, dosimetry plays a phase-dependent role: in early-phase studies, it is essential for establishing safety profiles and dose- toxicity correlations for organs at risk, while in later phases it contributes to efficacy assessment, treatment comparison, and long-term outcome evaluation. This webinar will provide an overview of the regulatory and methodological framework for integrating dosimetry into TRT clinical trials, with particular emphasis on its role in assessing safety, efficacy, and effects. Examples from recent and ongoing trials will be presented to illustrate how dosimetric data can inform trial design, support treatment personalization, and ultimately facilitate the transition toward dosimetry-guided therapeutic strategies.

• Provide an overview of the key elements involved in the design of clinical TRT trials.
• Explain the rationale and advantages of implementing dosimetry in TRT clinical trials.
• Identify key factors for designing dosimetry protocols tailored to the specific radiopharmaceutical and the phase of the clinical trial.”

• This webinar is intended for professionals involved in TRT, mainly nuclear medicine physicians,  technologists and medical physicists.