The demands for radiopharmaceutical dosimetry are growing rapidly. This need impacts design of clinical trials for a wide variety of oncologic diseases (e.g. neuroendocrine tumors (NETs), prostate cancer, lung, breast, and GI cancer) and is changing the way theragnostic trials are being conducted and designed. Biotech companies and nuclear medicine departments are focusing on dosimetric approaches that enhance therapeutic benefits to patients while adhering to regulatory authority requirements. Well informed dosimetry input is essential for achieving success in radiopharmaceutical therapy clinical trials.
In this webinar, Medpace experts explore the medical, operational, imaging, and regulatory considerations for radiopharmaceutical dosimetry. With a focus on solid tumors, we discuss the current landscape and how this may alter your approach to dosimetry and your overall program. We explore the challenges of conducting dosimetry in all phases of trials, offering insights into trial start-up, dosimetry conduct, collection, and implementation to seamlessly execute radiopharmaceutical therapy studies as part of your overall clinical development plan.
Join experts from Medpace’s radiation oncology and radiation imaging teams as they explore:
• Medical Considerations: Current dosimetry requirements in radiopharmaceutical programs; how this impacts your clinical development plans and overall strategy
• Imaging Advancements: The new and exciting aspect of dosimetry in oncology imaging for a variety of indications, with a deeper dive into solid tumors
Key Learning Objectives
- How radiopharmaceutical therapy dosimetry differs from external beam and diagnostic imaging dosimetry
- Clinical considerations in radiopharmaceutical dosimetry, integrating dosimetric data into Phase 1 trials and SRC discussions
- How the interactions between the imaging and clin ops CRO teams are crucial for the effective conduct of the trial
- The challenge of site imaging qualification and scanner calibration
- Data entry into EDC and impact on dosimetry data timelines and accuracy
Target Audience
- CMO,
- Mangers,
- Directors of Clinical Operations or Outsourcing
