Functional Imaging of Tumor and Normal Tissue - Full Text View

Sponsored by:	Duke University
Information provided by:	Duke University
ClinicalTrials.gov Identifier:	NCT00933114

Purpose

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.

Condition	Intervention
Head and Neck Cancer	Procedure: MRI and PET imaging

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	The Use of Functional Imaging to Quantify Tumor and Normal Tissue Physiology in Patients With Locally Advanced Head and Neck Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Further study details as provided by Duke University:

Primary Outcome Measures:

Temporal variability of permeability, perfusion, diffusion and glucose metabolism as measured in both tumor and the parotid gland [ Time Frame: At end of 1 week of radiation therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Time Frame: 1 year of completing radiation therapy ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	June 2009
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Functional Imaging Functional imaging with MRI and PET	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

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients presenting to Radiation Oncology for radiotherapy of the NH cancer.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00933114

Locations

United States, North Carolina
Duke University Medical Center, Department of Radiation Oncology	Recruiting
Durham, North Carolina, United States, 27710
Contact: David Yoo, MD 919-681-9743 yoo00001@mc.duke.edu
Contact: David m Brizel, MD 919 668-5637 david.brizel@duke.edu
Principal Investigator: David Yoo, MD
Principal Investigator: David M Brizel, MD
Sub-Investigator: Oana Craciunescu, PhD
Sub-Investigator: Jenny Hoang, MD
Sub-Investigator: Terence Wong, MD, PhD
Sub-Investigator: James MacFall, PhD

Sponsors and Collaborators

Duke University

Investigators

Principal Investigator:	David S Yoo, MD, PhD	Duke University Medical Center, Dept Radiation Oncology
Principal Investigator:	David M Brizel, MD	Duke University Medical Center Dept Radiation Oncology

More Information

Publications:

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.

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.

Responsible Party:	Duke University Medical Center, Department of Radiation Oncology ( David Yoo, MD )
Study ID Numbers:	Pro00014784
Study First Received:	July 2, 2009
Last Updated:	July 6, 2009
ClinicalTrials.gov Identifier:	NCT00933114 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Duke University:

DCE MRI
PET
Perfusion

Permeability
Cancer of the head and neck
Head, Neck neoplasms

Study placed in the following topic categories:

Head and Neck Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009