Quantitative Imaging Biomarker Prospective Validation of Dynamic Contrast-enhanced MRI as a Metric of Orodental Injury After Radiotherapy (QI-ProVE-MRI)

This prospective observational study will acquire DCE-MRI data from 200 evaluable patients, specifically with an elevated dosimetric risk to assure an event rate of 20% by 36 months post-radiation, sufficient to demonstrate biomarker performance in the clinical cohort most reflective of relative ORN risk. The final study cohort will consist of individuals undergoing definitive radiotherapy for primary head and neck malignancy. The study subjects will include patients with primarily elevated risk of ORN based on clinical (e.g., pre-RT dental procedures) and dosimetric risk factors we established in prior work (e.g., D30>50Gy, V44 ≥ 42%, or V58 ≥ 25%). All subjects will receive standard IMRT or IMPT as part of their standard clinical care, and treatment plans delivered will be in no way modified based on experimental imaging. Multi-parametric DCE-MRI imaging will be serially performed as per this study's manual of procedures. Clinical data regarding for evaluation of possible dental, mandibular, as well as other normal tissue organs-at-risk side effects will be collected prospectively from medical and dental records for correlation with the DCE-MRI imaging biomarkers. Functional outcomes and patient-reported outcomes questionnaires will be completed to detail outcomes of the continuum of treatment and survivorship.