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

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.

Condition or disease Intervention/treatment
Head and Neck Cancer Procedure: MRI and PET imaging

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.

Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: The Use of Functional Imaging to Quantify Tumor and Normal Tissue Physiology in Patients With Locally Advanced Head and Neck Cancer
Study Start Date : October 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Functional Imaging
Functional imaging with MRI and PET
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

Primary Outcome Measures :
  1. Permeability, perfusion, diffusion and glucose metabolism [ Time Frame: At end of 1 week of radiation therapy ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to Radiation Oncology for radiotherapy of the NH cancer.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00933114

United States, North Carolina
Duke University Medical Center, Department of Radiation Oncology
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
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

Responsible Party: Duke University Identifier: NCT00933114     History of Changes
Other Study ID Numbers: Pro00014784
First Posted: July 7, 2009    Key Record Dates
Last Update Posted: April 11, 2012
Last Verified: April 2012

Keywords provided by Duke University:
Cancer of the head and neck
Head, Neck neoplasms

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site