Functional Imaging of Tumor and Normal Tissue

Study Overview
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Brief Summary
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Dynamic contrast-enhanced (DCE) - magnetic resonance imaging (MRI), diffusion-weighted (DW)-MRI, and fludeoxyglucose - positron emission tomography - computed tomography (FDG-PET-CT) are three modalities that generate non-invasive, functional images of tumors and normal tissues based on physiologic properties including perfusion, vascular permeability and glucose metabolism. Demonstrating that these parameters are associated with clinical outcome, either efficacy or toxicity, could enhance the ability to select patients for different treatment strategies and improve the therapeutic ratio.

Detailed Description
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Patients will undergo functional imaging studies, DCE-MRI pre-treatment (twice) and after 1 week of Radiation Therapy (RT) and PET scans - pre-treatment and after 1 week of RT. Parotid gland saliva production will also be measured at baseline and at 3, 6, and 12 months of follow-up.

Official Title
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The Use of Functional Imaging to Quantify Tumor and Normal Tissue Physiology in Patients With Locally Advanced Head and Neck Cancer

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Procedure: MRI and PET imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically documented squamous cell carcinoma of the head and neck (AJCC stages II-IV, M0) Eligible anatomic sites: Oral cavity, oropharynx, hypopharynx, supraglottic and glottic larynx, or nasopharynx Curative intent concurrent chemoradiation Age > 18 years Karnofsky Performance Status > 60 Able to undergo MRI with contrast (gadolinium) and/or FDG PET scan Exclusion Criteria: Diabetes other than diet controlled MRI Absolute Contraindications including: Glomerular filtration rate < 60 ml/min Weight < 350 lb or current device limitations Metallic foreign bodies in the eye Cardiac pacemakers Clips in the central nervous system (ferromagnetic haemostatic) Automatic internal cardiac defibrillators Cochlear implants Shrapnel in vital locations Pregnant (positive pregnancy test) or lactating

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Functional Imaging<br>Functional imaging with MRI and PET | Procedure: MRI and PET imaging<br>* Dynamic Enhanced Magnetic Resonance Imaging (DEC-MRI) and positron emission tomography (PET) scan at baseline and after 1 week of radiation therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Permeability, perfusion, diffusion and glucose metabolism |  | At end of 1 week of radiation therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationships between baseline and treatment induced changes in vascular permeability, perfusion, interstitial space, glucose metabolism, and saliva production to identify prognostic and predictive parameter(s) for treatment |  | 1 year of completing radiation therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DCE MRI, PET, Perfusion, Permeability, Cancer of the head and neck, Head, Neck neoplasms