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

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ClinicalTrials.gov Identifier: NCT00994201
Recruitment Status : Terminated (Study never accrued sufficient subjects)
First Posted : October 14, 2009
Last Update Posted : March 25, 2016
Medical Research Foundation, Oregon
Radiological Society of North America
Information provided by (Responsible Party):
James Tanyi, OHSU Knight Cancer Institute

Brief Summary:
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 or disease Intervention/treatment
Head and Neck Cancer Other: 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.

Study Type : Observational
Actual Enrollment : 10 participants
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
Study Start Date : October 2011
Primary Completion Date : June 2015
Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Correlation between early/a prior marker and progression-free survival. [ Time Frame: September 2011 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00994201

United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
OHSU Knight Cancer Institute
Medical Research Foundation, Oregon
Radiological Society of North America
Principal Investigator: James A. Tanyi, PhD Oregon Health and Science University

Additional Information:
Responsible Party: James Tanyi, Clinical Associate Professor, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00994201     History of Changes
Other Study ID Numbers: OHSU IRB00005554
First Posted: October 14, 2009    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: March 2016

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