Theranostic Trial Alliance: Image-guided Diagnosis & Therapy with targeting Radiopharmaceuticals

Purpose and goal:

Theranostics Trial Alliance (TTA) Sweden is a strategic partnership of prominent Swedish clinics and universities, the Life Science sector and medical drug companies. TTA Sweden aims to promote the development, testing and clinical implementation of new antibody-based molecular therapeutic strategies within Precision Oncology in a streamlined manner and in the shortest time.

The TTA Sweden consortium is formed of partners, all of which are today independently operating. We will establish long-term relationships and a sustainable national network. Expected results and effects: - Establish a national framework for conduction of multicenter trials with radiolabeled drugs.

- Develop a workflow and standard operating processes for the planning, conducting and finalizing of clinical trials with radiopharmaceuticals. - Develop, install and validate a total-body PET adapted for theranostics applications. - Conduct a pilot multicenter clinical trial to test the concept of image-guided therapy.

- Perform health-economic analysis, the results of which could be used by authorities as a model for the deployment of image-guided strategies in clinical practice. Approach and implementation:

TTA Sweden is based on a diverse portfolio of actor and actions. The alliance will identify a pilot project to test central concept of “image-guided therapy” which will be targeted by all work packages (WP), i.e. a clinical trial focusing on HER2-PET and HER2-targeted treatments. Each WP will be able to have its own governance mechanism aligning with the greater whole.