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

July 2, 2009
April 10, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00933114 on ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
21
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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00933114
Pro00014784
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP