The EMINENCE Study - PET/MR Imaging of Head Neck Cancer

Study Overview
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Brief Summary
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Head and neck cancers (HNC) often receive radiotherapy as part of their treatment. However, unacceptable failure rates and severe side effects remain a challenge. The improvements in radiotherapy are closely related to improvements in medical imaging. Functional imaging, where intratumoural characteristics such as tumour oxygenation, metabolism, and blood vessel function can be quantified, offers possibilities to personalize the radiotherapy. In this study we will establish the clinical workflow for PET- and MRI-based radiotherapy in HNC by acquiring images prior to and during radiotherapy to develop new concepts for image-based biologically adaptive radiotherapy, both based on photon-based radiotherapy and also proton therapy, which soon will be available for cancer patients in Norway. The investigators aim to contribute towards further developments of personalised high-precision radiotherapy for HNC patients resulting in improved outcome, reduced side-effects and better quality of life.

Official Title
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The EMINENCE Study - PET/MR Imaging of Head Neck Cancer

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Diagnostic Test: FDG-PET/MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: willing and able to give full written consent according to the protocol approved by the Regional Ethics Committee histologically confirmed squamous cell carcinoma in the head neck region (pharynx, larynx, oral cavity or sinonasal area) locally advanced disease without sign of dissemination (T3/T4 and/or N1-3, M0) on diagnostic imaging scheduled for definitive radiotherapy with curative intent with or without concomitant chemotherapy adequate renal function: Creatinine clearance ≥ 60 ml/minute lymph node metastasis from cancer of unknown primary of the upper neck (i.e. level II-III) were PET/CT is negative outside the head-neck region can be considered for inclusion at the discretion of the study investigators. Exclusion Criteria: general contraindications for MRI (pacemaker, aneurysm clips, any form of metal in the body, severe claustrophobia) serious comorbidity (including previous or othe cancer) that in the opinion of the investigator would compromise the patient's ability to complete the study of interfere with the evaluation of the study objectives (e.g. poorly controlled diabetes mellitus) histologically confirmed SCC of same or other origin within the last five years patient wants to withdraw for any reason during the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients referred to fast track clinical pathway for HNC cancer<br>MRI as part of staging, including a 5-minute additional sequence. | |
| Patients with locally advanced HNC<br>FDG-PET/MRI | Diagnostic Test: FDG-PET/MRI<br>* Performed at baseline, interim and at 12-16 weeks post radiotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Population 1: Predict overall survival five years after treatment | For study population one, the primary study objective is to explore the potential of functional MR imaging parameters in predicting overall survival in head and neck cancer (HNC) five years after treatment. | Five years after treatment | 
| Population 2: Response three months after treatment | For study population two, the primary objective is response three months after treatment. | Three months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Populations 1 and 2: Time to local relapse and time to distant metastasis |  | Five years after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diagnostic Imaging, Functional Imaging, Nuclear magnetic Resonance Imaging, Positron-Emission Tomography, Radiotherapy