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Functional Imaging of Tumor and Normal Tissue (FITT)

This study has been terminated.
(Funding ceased)
Sponsor:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT00933114
First received: July 2, 2009
Last updated: April 10, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention
Head and Neck Cancer
 Procedure: MRI and PET imaging

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Permeability, perfusion, diffusion and glucose metabolism [ Time Frame: At end of 1 week of radiation therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: October 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients presenting to Radiation Oncology for radiotherapy of the NH cancer.

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
  • Pregnant (positive pregnancy test) or lactating
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00933114

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

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00933114     History of Changes
Other Study ID Numbers: Pro00014784
Study First Received: July 2, 2009
Last Updated: April 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Duke University:
DCE MRI
PET
Perfusion
 Permeability
Cancer of the head and neck
Head, Neck neoplasms

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

ClinicalTrials.gov processed this record on May 19, 2013