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.
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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New York
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New York、New York、美国、10065
- Memorial Sloan Kettering Cancer Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Inclusion criteria for the tongue carcinoma patients:
- Primary malignancy of the oral or base of tongue, Stage I-IV of AJCC staging system, planned for surgical or radiation therapy.
Inclusion criteria for the healthy subjects:
- Healthy adult subjects between the ages of 21-75 years.
Exclusion Criteria:
Exclusion criteria for the tongue carcinoma patients include the following:
- History of significant psychiatric condition (e.g. schizophrenia, obsessive-compulsive disorder, significant dementia),
- History of the following neurological conditions: CVA, seizure disorders, demyelinating conditions, systemic neuromuscular disorders, cerebral palsy, Alzheimer's disease.
- History of previous moderate to severe traumatic brain injury.
- History of significant cardiovascular, respiratory, gastrointestinal or renal disease (e.g.myocardial infarction within the previous 12 months, significant vaso-occlusive disease,severe or advanced asthma, COPD, emphysema, gastroesophageal reflux disease, or renal compromise)
- History of achalasia
- History of other neoplasms involving the brain, head and neck, or gastrointestinal system.
- History of dysphagia, odynophagia, or aphasia unrelated to present illness.
- History of significant claustrophobic reactions.
- Standard contraindications to MR examinations (e.g. implanted stimulators).
Exclusion criteria for the healthy subjects includes the all of the conditions listed for the tongue:
- Carcinoma patients and additionally includes history of significant surgery or previous radiation therapy to the head and neck
- Previous history of dysphagia, odynophagia, aphasia, pregnancy,and standard contraindications to MR examinations.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:1个
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Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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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.
大体时间:7 years
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7 years
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次要结果测量
结果测量 |
大体时间 |
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Determine relationship between mechanisms of adaptation at level of central nervous system to alterations in function in the tongue.
大体时间:7 years
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7 years
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Determine changes in cortical activity in representation of tongue movement that occur pre and post-treatment.
大体时间:7 years
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7 years
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Determine the central neural response to direct peripheral rehabilitation strategies.
大体时间:conclusion of study
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conclusion of study
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
MRI的临床试验
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)终止
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Memorial Sloan Kettering Cancer CenterNational Institutes of Health (NIH)主动,不招人
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Memorial Sloan Kettering Cancer Center终止
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Memorial Sloan Kettering Cancer Center招聘中