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The Use of Functional Imaging to Quantify Tumor and Normal Tissue Physiology in Patients With Locally Advanced Head and Neck Cancer


N/A
18 Years
80 Years
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

The Use of Functional Imaging to Quantify Tumor and Normal Tissue Physiology in Patients With Locally Advanced Head and Neck Cancer


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Permeability, perfusion, diffusion and glucose metabolism

Outcome Time Frame:

At end of 1 week of radiation therapy

Safety Issue:

No

Principal Investigator

David S Yoo, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Duke University Medical Center, Dept Radiation Oncology

Authority:

United States: Institutional Review Board

Study ID:

Pro00014784

NCT ID:

NCT00933114

Start Date:

October 2009

Completion Date:

September 2011

Related Keywords:

  • Head and Neck Cancer
  • DCE MRI
  • PET
  • Perfusion
  • Permeability
  • Cancer of the head and neck
  • Head, Neck neoplasms
  • Head and Neck Neoplasms

Name

Location
Duke University Medical Center, Department of Radiation Oncology Durham, North Carolina  27710