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Magnetic Resonance Imaging (MRI) in the Assessment of Head and Neck Squamous Cell Carcinoma (HNSCC) Response

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Oregon Health and Science University
Sponsor:
Collaborators:
Medical Research Foundation, Oregon
Radiological Society of North America
Information provided by (Responsible Party):
James A. Tanyi, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT00994201
First received: October 13, 2009
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

The purpose of this study is to see if new techniques of measuring HNSCC tumors with magnetic resonance imaging (MRI) can help predict how well the tumors will respond to combined chemotherapy and radiation treatment. The investigators hope to find a reliable method to determine whether or not a patient's cancer is responding to chemo-radiation early in their treatment using an MRI, such that that cancer treatments could be tailored to the individual more effective in the future. The MRI techniques include dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), diffusion-weighted magnetic resonance imaging (DW-MRI), and magnetic resonance spectroscopy (MRS). Participants will be subjected to two sessions of MRI scans: one before the initiation of their regular treatment and the second before their second cycle of chemotherapy. Each scanning session will last approximately 45 minutes.


Condition Intervention
Head and Neck Cancer
Other: DCE-MRI, DW-MRI and MRS

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Pilot Study of DCE-MRI, DW-MRI, and MRS in the Assessment of Head and Neck Cancer Response to Chemo-radiation

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Determination of early or a prior prognostic markers of head and neck cancers, as measured by DCE-MRI, DW-MRI, and MRS, that characterize the differences between clinical responders and non-responders. [ Time Frame: September 2011 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between early/a prior marker and progression-free survival. [ Time Frame: September 2011 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: DCE-MRI, DW-MRI and MRS

    Patients will undergo Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), Diffusion-weighted magnetic resonance imaging (DW-MRI), Magnetic resonance spectroscopy (MRS) prior to the initiation of chemoradiation and before their second cycle of chemotherapy.

    Healthy volunteers will undergo DCE-MRI, DW-MRI and MRS.

Detailed Description:

DCE-MRI, DW-MRI, MRS have the potential to measure early cellular changes that occur in response to successful therapies, such as chemoradiation, and have been demonstrated to be early predictors not only of therapeutic response, but also of overall survival for other malignancies. Our long-term goal is to use these imaging techniques to develop non-invasive functional imaging methodologies that would be better predictors of pathological response than the current clinical standard.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Potential subjects will be recruited by the Oregon Health and Science University head and neck oncology staff.

Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of loco-regionally advanced (stage III or IV) squamous cell carcinoma of the head and neck (oropharynx, hypopharynx and larynx)
  • Age > 18 years
  • No prior surgery, chemotherapy or radiation therapy for head and neck cancer
  • Scheduled to receive chemoradiation for definitive therapy

Exclusion Criteria:

  • Contraindications to MRI (pacemaker, aneurysm clip, mechanical and/or electrical device or metallic fragment, severe claustrophobia)
  • Contraindications to gadolinium
  • Severe, active co-morbidity
  • Major medical illnesses or psychiatric impairments
  • Pregnant or nursing women
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00994201

Contacts
Contact: James A. Tanyi, PhD 503-494-8756 tanyij@ohsu.edu
Contact: John M. Holland, MD 503-494-8756 hollanjo@ohsu.edu

Locations
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: James A. Tanyi, Ph.D.    503-494-8756    tanyij@ohsu.edu   
Contact: John M. Holland, M.D.    503-494-8756    hollanjo@ohsu.edu   
Sponsors and Collaborators
Oregon Health and Science University
Medical Research Foundation, Oregon
Radiological Society of North America
Investigators
Principal Investigator: James A. Tanyi, PhD Oregon Health and Science University
  More Information

Additional Information:
No publications provided

Responsible Party: James A. Tanyi, Clinical Associate Professor, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT00994201     History of Changes
Other Study ID Numbers: OHSU IRB00005554
Study First Received: October 13, 2009
Last Updated: December 10, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on November 25, 2014