Functional Imaging of Tumor and Normal Tissue (FITT)

Duke University

Status: Terminated

Conditions: Head and Neck Cancer

Treatments: Procedure: MRI and PET imaging

Study type: Observational

Funder types: Other

Identifiers

NCT00933114

Pro00014784

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

21 participants in 1 patient group

Functional Imaging

Description:

Functional imaging with MRI and PET

Treatment:

Procedure: MRI and PET imaging