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Functional Imaging of Tumor and Normal Tissue

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00933114
Acronym
FITT
Enrollment
21
Registered
2009-07-07
Start date
2009-10-31
Completion date
2011-09-30
Last updated
2012-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

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

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.

Interventions

PROCEDUREMRI 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

Sponsors

Duke University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Permeability, perfusion, diffusion and glucose metabolismAt end of 1 week of radiation therapy

Secondary

MeasureTime frame
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 treatment1 year of completing radiation therapy

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026