Evaluation of OE-MRI in Patients With H&N Cancer

Study Overview
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Brief Summary
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Assessment of the use of oxygen enhanced MRI scanning in a cohort of patients with head and neck squamous cell carcinomas to identify areas of hypoxia with tumours and relate this to treatment outcomes.

Detailed Description
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Oxygen-enhanced MRI (OE-MRI) is a technique being actively investigated for imaging hypoxia within cancer tissues. Preliminary clinical data demonstrates the feasibility of using this methodology to study patients with head and neck squamous cell carcinoma (HNSCC). The investigators wish to investigate using this methodology to identify hypoxic subvolumes within HNSCC that may have greater resistance to standard radiotherapy treatment and investigate the association of such hypoxic regions with treatment outcomes.

Official Title
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Evaluation of Oxygen Enhanced Magnetic Resonance Imaging for Identification of Hypoxia Induced Resistant Tumours in Patients With Head and Neck Cancer

Conditions
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Head and Neck Squamous Cell Carcinoma

Intervention / Treatment
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* Diagnostic Test: Oxygen Enhanced MRI scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-patient Volunteer Inclusion Criteria: Age 18 years and above Signed written informed consent Patient Inclusion Criteria: Histologically proven or strong clinical suspicion of squamous cell carcinoma of the head and neck Suitable for undergoing radical radiotherapy or chemoradiotherapy according to local protocols within the head and neck Cancer MDT Age 18 years and above Adequate physical fitness (WHO performance status 0 to 2) Signed written informed consent Exclusion Criteria: Non-patient Volunteer Exclusion Criteria: Contraindications to MRI scans as identified following completion of the Nottingham University Hospitals NHS Trust (NUH) standard MR safety screening protocol Severe Chronic Obstructive Pulmonary Disease (COPD) who are at risk of type 2 respiratory failure or require supplemental oxygen Volunteers who are pregnant as identified through the NUH standard MR safety screening protocol Patient Exclusion Criteria: Poor physical fitness (WHO performance status greater than 2) Contraindications to MRI scans as identified following completion of the NUH standard MR safety screening protocol Severe Chronic Obstructive Pulmonary Disease (COPD) who are at risk of type 2 respiratory failure or require supplemental oxygen Patients who are pregnant or breast-feeding (due to IV contrast use in the routine clinical scan) as identified through the NUH standard MR safety screening protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-patient volunteers<br>5 non-patient volunteers for testing of protocol to allow for the ascertaining of good quality data prior to the scanning of patients. | Diagnostic Test: Oxygen Enhanced MRI scan<br>* Dynamic MRI scanning switching from breathing room air to high concentration oxygen part way through the scan.<br>|
| Patients<br>50 patients to be scanned with the oxygen enhanced MRI scan protocol prior to definitive curative intent therapy. | Diagnostic Test: Oxygen Enhanced MRI scan<br>* Dynamic MRI scanning switching from breathing room air to high concentration oxygen part way through the scan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with areas detected within tumours of the head and neck area that have measurable hypoxia using OE-MRI technique. | Feasibility of OE-MRI scans to detect hypoxic areas within tumours in patients with head and neck squamous cell carcinomas | 2 years | 
| Association with treatment failure | Test predictive value of OE-MRI to identify patients with the highest risk of treatment failure and provide data to allow a power calculation for a larger future trial of the predictive power of OE-MRI for treatment outcomes in head and neck cancer treated with radiotherapy. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour perfusion | Assessment of routinely used diagnostic MRI images to identify non-perfused parts of tumours in combination with oxygen maps | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxygen enhanced MRI