Magnetic Resonance Imaging (MRI) in the Assessment of Head and Neck Squamous Cell Carcinoma (HNSCC) Response
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
| 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) |
-
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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
Contacts and Locations| Contact: James A. Tanyi, PhD | 503-494-8756 | tanyij@ohsu.edu |
| Contact: John M. Holland, MD | 503-494-8756 | hollanjo@ohsu.edu |
| 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 | |
| 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:
|
Carcinoma, Squamous Cell Head and Neck Neoplasms Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site |
ClinicalTrials.gov processed this record on May 23, 2013