The Use of Functional Imaging to Quantify Tumor and Normal Tissue Physiology in Patients With Locally Advanced Head and Neck Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Head and Neck Cancer
- Sponsor
- Duke University
- Enrollment
- 21
- Locations
- 1
- Primary Endpoint
- Permeability, perfusion, diffusion and glucose metabolism
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
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(1 year of completing radiation therapy)