Functional Imaging of Tumor and Normal Tissue (FITT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00933114
Recruitment Status : Terminated (Funding ceased)
First Posted : July 7, 2009
Last Update Posted : April 11, 2012
Information provided by (Responsible Party):
Duke University

July 2, 2009
July 7, 2009
April 11, 2012
October 2009
September 2011   (Final data collection date for primary outcome measure)
Permeability, perfusion, diffusion and glucose metabolism [ Time Frame: At end of 1 week of radiation therapy ]
Temporal variability of permeability, perfusion, diffusion and glucose metabolism as measured in both tumor and the parotid gland [ Time Frame: At end of 1 week of radiation therapy ]
Complete list of historical versions of study NCT00933114 on Archive Site
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 ]
Same as current
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Functional Imaging of Tumor and Normal Tissue
The Use of Functional Imaging to Quantify Tumor and Normal Tissue Physiology in Patients With Locally Advanced Head and Neck Cancer
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.
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Patients presenting to Radiation Oncology for radiotherapy of the NH cancer.
Head and Neck Cancer
Procedure: MRI and PET imaging
Dynamic Enhanced Magnetic Resonance Imaging (DEC-MRI) and positron emission tomography (PET) scan at baseline and after 1 week of radiation therapy
Functional Imaging
Functional imaging with MRI and PET
Intervention: Procedure: MRI and PET imaging

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 2011
September 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Duke University
Duke University
Not Provided
Principal Investigator: David S Yoo, MD, PhD Duke University Medical Center, Dept Radiation Oncology
Principal Investigator: David M Brizel, MD Duke University Medical Center Dept Radiation Oncology
Duke University
April 2012