Multiparametric magnetic resonance imaging in mucosal primary head and neck cancer: a prospective imaging biomarker study.
BACKGROUND
Radical radiotherapy, with or without concomitant chemotherapy forms the mainstay of organ preservation approaches in mucosal primary head and neck cancer. Despite technical advances in cancer imaging and radiotherapy administration, a significant proportion of patients fail to achieve a complete response to treatment. For those patients who do achieve a complete response, acute and late toxicities remain a cause of morbidity. A critical need therefore exists for imaging biomarkers which are capable of informing patient selection for both treatment intensification and de-escalation strategies.


METHODS/DESIGN
A prospective imaging study has been initiated, aiming to recruit patients undergoing radical radiotherapy (RT) or chemoradiotherapy (CRT) for mucosal primary head and neck cancer (MPHNC). Eligible patients are imaged using FDG-PET/CT before treatment, at the end of week 3 of treatment and 12 weeks after treatment completion according to local imaging policy. Functional MRI using diffusion weighted (DWI), blood oxygen level-dependent (BOLD) and dynamic contrast enhanced (DCE) sequences is carried out prior to, during and following treatment. Information regarding treatment outcomes will be collected, as well as physician-scored and patient-reported toxicity.


DISCUSSION
The primary objective is to determine the correlation of functional MRI sequences with tumour response as determined by FDG-PET/CT and clinical findings at 12 weeks post-treatment and with local control at 12 months post-treatment. Secondary objectives include prospective correlation of functional MRI and PET imaging with disease-free survival and overall survival, defining the optimal time points for functional MRI assessment of treatment response, and determining the sensitivity and specificity of functional MRI sequences for assessment of potential residual disease following treatment. If the study is able to successfully characterise tumours based on their functional MRI scan characteristics, this would pave the way for further studies refining treatment approaches based on prognostic and predictive imaging data.


TRIAL REGISTRATION
Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12616000534482 (26 April 2016).
['Rumley|Christopher N|CN|', 'Lee|Mark T|MT|', 'Holloway|Lois|L|', 'Rai|Robba|R|', 'Min|Myo|M|', 'Forstner|Dion|D|', 'Fowler|Allan|A|', 'Liney|Gary|G|']
D015415:Biomarkers D002985:Clinical Protocols D003131:Combined Modality Therapy D019788:Fluorodeoxyglucose F18 D006258:Head and Neck Neoplasms D006801:Humans D008279:Magnetic Resonance Imaging D009092:Mucous Membrane D000072078:Positron Emission Tomography Computed Tomography D049268:Positron-Emission Tomography D011446:Prospective Studies D016896:Treatment Outcome
Head and neck cancer MRI Chemoradiation Diffusion-weighted imaging Dynamic contrast-enhanced MRI Functional imaging Hypoxia Predictive role