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Sep 28
Education

EDU 36 - Physics Considerations for RPT Clinical Trials: Identifying Barriers, Evaluating Institutional Readiness and Defining Oversight Frameworks

05:00pm - 06:00pm ET
Radiation and Cancer Physics
Physicists

MODERATOR(S)

Joseph Steiner, PhD, DABR - University of Chicago

session DESCRIPTION

Following the success of the NETTER-1 and VISION trials, radiopharmaceutical therapy (RPT) has experienced rapid and exponential growth within the oncology treatment landscape. This has led to a similar rapid and exponential increase in RPT clinical trials; currently on ClinicalTrials.gov, a search of keywords Lu-177, Ac-225, Pb-212 and Y-90 results in 379 trials that are not yet recruiting, recruiting and/or active. These RPT trials span Phase I, Phase II and Phase III and are often at the bleeding edge of cancer therapy, prompting forward-thinking health care institutions to enroll their patients whenever possible. However, RPT clinical trials present unique challenges that these institutions, even if they provide routine clinical RPT, may find difficult to address, ranging from complex site qualification procedures to lack of staff qualifications for pharmacokinetic sampling of radioactive biologic fluids. In this session, typical challenges and obstacles associated with initializing and participating in RPT clinical trials within clinical health care environments will be outlined. The attendees will be provided with information on institutional (staff and equipment) requirements and recommendations for performing RPT clinical trials. While solutions to RPT trial challenges are very institution dependent, general frameworks such as the development of RPT trial review committees and trial initiation worksheets will be presented and discussed. The goal of this session is to prepare attendees to embark upon the path of performing RPT clinical trials and/or improve on their current RPT trial practice.

learning objectives

  1. Identify unique and challenging aspects of RPT clinical trials.
  2. Identify their institutional abilities to support RPT clinical trials and improve in any deficient area.
  3. Develop site specific committees and/or workflows to review potential RPT clinical trials and to ensure when enrolled, the likelihood of adverse events or deficiencies is as small as possible.

Credits

AMA PRA Category 1 Credits: 1.00

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