Magnetic Resonance Imaging (MRI) in the Assessment of Head and Neck Squamous Cell Carcinoma (HNSCC) Response
Recruitment status was Recruiting
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.
|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|
- 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 ]
- Correlation between early/a prior marker and progression-free survival. [ Time Frame: September 2011 ] [ Designated as safety issue: No ]
|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)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00994201
|Contact: James A. Tanyi, PhDfirstname.lastname@example.org|
|Contact: John M. Holland, MDemail@example.com|
|United States, Oregon|
|Oregon Health and Science University||Recruiting|
|Portland, Oregon, United States, 97239-3098|
|Contact: James A. Tanyi, Ph.D. 503-494-8756 firstname.lastname@example.org|
|Contact: John M. Holland, M.D. 503-494-8756 email@example.com|
|Principal Investigator:||James A. Tanyi, PhD||Oregon Health and Science University|