FITT: Functional Imaging of Tumor and Normal Tissue
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Permeability, perfusion, diffusion and glucose metabolism [At end of 1 week of radiation therapy]
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 [1 year of completing radiation therapy]
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
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.
- Kirkpatrick JP, Cárdenas-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.
- Pro00014784