HN-QUEST: A Study of Head and Neck Imaging Biomarkers

Study Overview
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Brief Summary
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This is a multi arm, single center, investigator initiated study to investigate online adaptive radiotherapy and biomarker development in patients with newly diagnosed HNSCC (Head and Neck Squamous Cell Carcinoma) receiving curative therapy. The study will consist of two prospective arms. In Arm 1 up to 100 HNSCC patients receiving (CT)RT (computed tomography-based radiation therapy) will receive up to weekly non-contrast MRI (magnetic resonance imaging) scans during treatment. Arm 2 consists of two cohorts. In cohort A up to 20 healthy volunteers will undergo non-contrast MRI at two time points. In cohort B up to 53 patients planned to receive curative (chemo) radiotherapy for HNSCC will undergo two baseline MRI scans, one MRI in week 2 and week 4, and final MRI scan 6-8 weeks after completion of treatment.

Detailed Description
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The purpose of this study is to develop and investigate novel and established MR (magnetic resonance) imaging sequences as predictive and prognostic radiotherapy biomarkers. Radiotherapy is a fundamental treatment modality for Head and Neck Squamous Cell Carcinoma (HNSCC) with a majority of patients receiving radiation as part of their care pathway. Although treatment is effective, there remains a risk of failure particularly in those presenting with locally advanced disease. In addition, significant proportion of patients receiving radiotherapy will suffer long-term side effects related to their treatment. The addition of concurrent chemotherapy improves the efficacy of radiotherapy, but at the cost of increased treatment related toxicity. The treatment related toxicity and risk of treatment failure means there is a compelling clinical need to personalize therapy based on a patient's early response to radiotherapy.

Official Title
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HN QUEST- Evaluation of Online MRgRT and Repeat Functional Imaging in Patients Undergoing Curative (CT)RT for HN Malignancy

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Other: MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for Cancer Patients: Age >/= 18 years Histologically proven Head and Neck Squamous Cell carcinoma Primary or nodal disease > 3cm for biomarker imaging Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2 Planned for curative surgery or (chemo)radiotherapy Willingness to undergo repeat MRI Able to receive and understand verbal and written information regarding study and able to give written informed consent Adequate renal function: Calculated creatinine clearance >/= 30ml/min Be able to lie comfortably on back for 1 hour Exclusion Criteria for Cancer Patients: As judged by investigator evidence of systemic disease that makes unsuitable for study Contra-indication for serial MRI scans Previous solid tumor treated within last 5 years Pregnancy History of significant obstructive airway disease History of gadolinium contrast allergy Inclusion Criteria for Healthy Volunteers Age >/= 18 years Able to receive and understand verbal and written information regarding study and able to give written informed consent Willingness to undergo repeat MRI Exclusion Criteria for Healthy Volunteers Unwillingness to sign informed consent Contra-indication for MRI Underlying significant respiratory disease

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HNSCC patients<br>Up to 100 HNSCC patients receiving CT-based radiation therapy will receive up to weekly non-contrast MRI scans during treatment. | Other: MRI<br>* Non-invasive imaging technique that is used to take pictures of organs within the body.<br>|
| Other: Healthy volunteers and HNSCC patients<br>Cohort A - Up to 20 healthy volunteers will undergo non-contrast MRI at two time points. Cohort B - Up to 53 patients planned to receive curative (chemo) radiotherapy for HNSCC will undergo two baseline MRI scans, one MRI in week 2 and week 4, and final MRI scan 6-8 weeks after completion of treatment. | Other: MRI<br>* Non-invasive imaging technique that is used to take pictures of organs within the body.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hypoxia level during radiotherapy as assessed by fMRI (functional magnetic resonance imaging) | fMRI images will be used to assess tumour hypoxia status for Head and Neck Squamous Cell Carcinoma (HNSCC) | Baseline, Week 2 and 4 of radiotherapy, Week 6-8 post radiotherapy | 
| Change in tumour tissue and microenvironment during radiotherapy as assessed by fMRI | fMRI images will be used to evaluate on treatment tumour response to determine the effect of dose escalation to tumor sub regions using a daily online adaptive radiation treatment approach | Weekly MRI imaging during radiotherapy (Up to 7 weeks) |