Functional Imaging of Tumor and Normal Tissue

Duke University21 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Head and Neck Cancer

Interventions

MRI and PET imagingPROCEDURE

Dynamic Enhanced Magnetic Resonance Imaging (DEC-MRI) and positron emission tomography (PET) scan at baseline and after 1 week of radiation therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Duke University Medical Center, Department of Radiation Oncology

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Permeability, perfusion, diffusion and glucose metabolism

Time frame: At end of 1 week of radiation therapy

Secondary Outcomes

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

Time frame: 1 year of completing radiation therapy

Data from ClinicalTrials.gov

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