Improving Therapeutic Outcomes in the Tongue Carcinoma Patient: Assessment of Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging
The purpose of this study is to see how the brain re-learns to control the tongue in speaking and swallowing when either portions of the tongue have been removed, or when the tongue has been treated with radiation, in order to treat cancer. We hope the results of this study will help us to improve healing for patients who are being treated for cancer of the tongue.
When patients with cancer of the tongue are treated by removing parts of the tongue (surgery) or by destroying the cancer with radiation to the tongue, they have significant difficulty speaking and swallowing after such treatments. At this time, patients who have been treated for cancer of the tongue re-learn speaking and swallowing through exercises taught by a speech pathologist.
What is needed is information on how the brain re-learns to control speaking and swallowing so that we can help these patients re-learn faster after their treatments.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Improving Therapeutic Outcomes in the Tongue Carcinoma Patient: Assessment of Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging|
- To utilize fMRI to characterize adaptation to alterations in tongue morphology & function following either surgical therapy, or radiation/chemotherapy to tongue in patients undergoing treatment of malignancies involving the tongue. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- Determine relationship between mechanisms of adaptation at level of central nervous system to alterations in function in the tongue. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- Determine changes in cortical activity in representation of tongue movement that occur pre and post-treatment. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
- Determine the central neural response to direct peripheral rehabilitation strategies. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]
|Study Start Date:||November 2002|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging
The purpose of this investigation is to determine cortical mechanisms of adaptation to surgical or radiation treatment to the tongue. This study will use a non-invasive imaging technique, Functional Magnetic Resonance Imaging (fMRI), to investigate cortical responses to partial glossectomy or radiation therapy for treatment of a tongue malignancy. Patients with Stage I-IV (AJCC) malignancies of the tongue who are treated with surgery and or radiation therapy will be imaged using fMRI pre-operatively and at approximately six months postoperatively.
Patterns of brain activity from the fMRI studies will be compared with matched healthy control subjects. The results of this investigation will provide needed information on both central and peripheral mechanisms of adaptation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00594724
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Kyung Peck, PhD||Memorial Sloan Kettering Cancer Center.|