Functional Imaging of Tumor and Normal Tissue

Terminated

• Conditions: Head and Neck Cancer
• Interventions: Procedure: MRI and PET imaging

• Registration Number: NCT00933114
• Lead Sponsor: Duke University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-06
• Study First Posted: 2009-07-07
• Study Start: 2009-10
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-10
• Last Update Posted: 2012-04-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Functional Imaging	MRI and PET imaging	Functional imaging with MRI and PET

Primary Outcome Measures

Name	Time	Method
Permeability, perfusion, diffusion and glucose metabolism	At end of 1 week of radiation therapy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Duke University Medical Center, Department of Radiation Oncology; 🇺🇸 Durham, North Carolina, United States