Clinical trial NCT00933114: Functional Imaging of Tumor and Normal Tissue
Official title: The Use of Functional Imaging to Quantify Tumor and Normal Tissue Physiology in Patients With Locally Advanced Head and Neck Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Head and Neck Cancer
Keywords: DCE MRI
PET
Perfusion
Permeability
Cancer of the head and neck
Head, Neck neoplasms
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-07-07
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting to Radiation Oncology for radiotherapy of the NH cancer.

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.

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 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

Primary outcomes:
measure: Permeability, perfusion, diffusion and glucose metabolism
timeFrame: At end of 1 week of radiation therapy
Secondary outcomes:
measure: 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
timeFrame: 1 year of completing radiation therapy
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center, Department of Radiation Oncology
state: North Carolina
Study officials:
affiliation: Duke University Medical Center, Dept Radiation Oncology
name: David S Yoo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University Medical Center Dept Radiation Oncology
name: David M Brizel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.