Functional Imaging of Tumor and Normal Tissue

Head and Neck Cancer Clinical Trial

— FITT  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00933114
• Other study ID #: Pro00014784
• Status: Terminated
• Phase: N/A
• First received: July 2, 2009
• Last updated: April 10, 2012
• Start date: October 2009
• Est. completion date: September 2011

Study information

• Verified date: April 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Procedure:
• MRI 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

Locations

Country	Name	City	State
United States	Duke University Medical Center, Department of Radiation Oncology	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Kirkpatrick JP, Cárdenas-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Permeability, perfusion, diffusion and glucose metabolism		At end of 1 week of radiation therapy	No
Secondary	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	No