Functional Imaging of Tumor and Normal Tissue (FITT)

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.

Study Overview

• Status: Terminated
• Conditions: Head and Neck Cancer
• Intervention / Treatment: 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
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center, Department of Radiation Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Permeability, perfusion, diffusion and glucose metabolism	At end of 1 week of radiation therapy

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Brizel DM, Rosner GL, Prosnitz LR, Dewhirst MW. Patterns and variability of tumor oxygenation in human soft tissue sarcomas, cervical carcinomas, and lymph node metastases. Int J Radiat Oncol Biol Phys. 1995 Jul 15;32(4):1121-5. doi: 10.1016/0360-3016(95)00106-9.
• Kirkpatrick JP, Cardenas-Navia LI, Dewhirst MW. Predicting the effect of temporal variations in PO2 on tumor radiosensitivity. Int J Radiat Oncol Biol Phys. 2004 Jul 1;59(3):822-33. doi: 10.1016/j.ijrobp.2004.02.015.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: July 2, 2009
• First Submitted That Met QC Criteria: July 6, 2009
• First Posted (Estimate): July 7, 2009

Study Record Updates

• Last Update Posted (Estimate): April 11, 2012
• Last Update Submitted That Met QC Criteria: April 10, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: PET; Perfusion; DCE MRI; Permeability; Cancer of the head and neck; Head, Neck neoplasms
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: Pro00014784