MRI/S Biomarkers of Toxicity
Member-Initiated Symposium

ORGANIZERS: John Waterton

Thursday, 16 May 2019

Session Number: MIS-21

Overview
Most treatments, such as drugs or radiotherapy, cause harm as well as bring benefits. Balancing risks and harms against benefits is the main duty of regulatory authorities such as FDA and EMA. MR has a growing role providing biomarkers (BM) of toxicity. However, different considerations apply besides MRBMs of efficacy. For example, MRBMs of efficacy usually involve measurements pre- and post-treatment, so repeatability is the important metric. On the other hand, MRBMs of toxicity would often be used after an undesired adverse effect, where pre-treatment scans are unavailable, so reproducibility is the important metric. Also, since adverse effects are unpredicted, studies could be required at any center, not just academic centers.

MRBMs of treatment efficacy feature very strongly in other sessions in this meeting. MRBMs of treatment toxicity are entirely complementary. Four study groups (Cardiac, Drug Research, Cancer, Psychiatric) provided advice on the design of this session.

The FDA/NIH BEST Resource (2016) re-affirms the importance both of imaging BM and of safety (toxicity) BM. In Europe, IMI has a specific investment in imaging BM of toxicity (www.imi-tristan.eu).

Target Audience
Scientists and physicians who invent and validate MR biomarkers; drug developers, regulators, and physicians who use MR biomarkers.

Educational Objectives
As a result of attending this course, participants should be able to:
- Describe the development, validation and role of MR biomarkers in assessing harms (toxicity) and risks-of-harm and distinguish this from the more familiar role of MR biomarkers in assessing efficacy benefits from therapeutic treatment; 
- List some MR biomarkers of toxicity in at least four different organ systems; and
- Explain to the MR scientist or radiologist the opportunities and challenges in the development and deployment of MR toxicity biomarkers.