Abstract
PURPOSE: Advancements in radionuclide imaging and therapy techniques have created a groundswell of enthusiasm in the recently designated field of theranostics. This has increased the need for facilities that are able to participate in clinical trials for investigational theranostic agents. Theranostics clinical trials present several unique challenges that will tax the resources and staff of most medical centers. Our purpose is to describe the unique logistical and administrative challenges associated with theranostics clinical trials, propose strategies for addressing them, and make recommendations regarding trial conduct to the community at large. APPROACH: The authors' experiences reviewing, implementing, and managing theranostics trials at their institution were used to identify common activities and challenges. RESULTS: Several key categories of requirements and challenges were identified. Multidisciplinary teams consisting of nuclear medicine, oncology, nursing, clinical research, and administrative staff are necessary to adequately perform all trial-related activities. Strategies are proposed to address these challenges and activities at the institutional and industry levels. CONCLUSION: The unique challenges inherent to theranostics clinical trials require a focused investment of time, effort, and resources from all stakeholders. Institutions that wish to participate in these trials must develop the infrastructure necessary to fully support the breadth of activities they require. Implementation of the strategies and recommendations presented here will ensure the successful conduct of these trials and will improve efficiency across the community.