Use of PET-MR in Head and Neck Cancer Patients - Diagnostic and Therapeutic Applications

Study Overview
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Brief Summary
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The primary research question to be answered in this project is Are patients with locally-advanced head and neck cancer able to tolerate a PET-MRI scan when they are immobilised in a radiotherapy treatment shell? This will be assessed by measuring the proportion of patients that complete the full scanning protocol and by obtaining participant feedback on their experience of completing the scan. The secondary question is Can a PET-MRI scan fused with a planning CT scan improve the accuracy in radiotherapy planning of patients with head and neck cancer? Accuracy will be assessed by: Comparing the radiotherapy target volumes and radiotherapy plans with and without the use of a PET-MRI scan. Comparing inter- and intra-observer variability in treatment contours with and without the use of a PET-MRI scan within and between oncologists and implications of that.

Official Title
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Use of PET-MR in Head and Neck Cancer Patients - Diagnostic and Therapeutic Applications

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Diagnostic Test: PET-MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years or over Able to give informed written consent. New diagnosis of biopsy-proven head and neck cancer. WHO performance status ≤ 2. MDT-recommended treatment with radical radiotherapy, with or without concurrent systemic therapy. MRI and PET-CT staging scans for diagnosis. Exclusion Criteria: Known intolerance/sensitivity to 18F-2-deoxyglucose or gadolinium-containing contrast agents. Claustrophobia or other contraindications to MRI. Unable to pass through a 55 cm hula hoop. Female patients that are pregnant or breastfeeding. Unable to understand written or spoken English. Patients not undergoing radical intent radiotherapy. Patients with stage 4 or 5 chronic kidney disease or other biochemical abnormalities e.g. uncontrolled blood glucose levels which can have an impact on PET-MRI imaging or contrast administration.

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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PET-MRI within 1 week of planning scan.<br>Patients would not normally have a PET-MRI as well as planning scan. In this experimental arm, patients will be given a PET-MRI within 1 week of the planning scan. | Diagnostic Test: PET-MRI<br>* Patients that participate in the current study will have an extra PET-MRI scan, which will expose them to a small amount (4 - 6 mSv) of extra radiation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of PET-MRI | To assess the proportion of patients completing the full PET-MRI scans when they are immobilised in a radiotherapy treatment shell. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of additional PET-MRI on radiotherapy planning | The secondary objective is to obtain pilot data on assessing the impact of the additional PET-MRI scan on the precision of radiotherapy planning. This will be assessed by comparing the radiotherapy target volumes and treatment plans with and without the use of PET-MRI scan. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head, Neck, Cancer, PET MRI