Back to resultsImproving Therapeutic Outcomes in the Tongue Carcinoma Patient: Assessment of Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging
Primary Purpose
Tongue Carcinoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Tongue Carcinoma focused on measuring Tongue, Carcinoma, Cancer, 02-093
Eligibility Criteria
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.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Determine relationship between mechanisms of adaptation at level of central nervous system to alterations in function in the tongue.
Determine changes in cortical activity in representation of tongue movement that occur pre and post-treatment.
Determine the central neural response to direct peripheral rehabilitation strategies.
Full Information
NCT ID
NCT00594724
First Posted
January 7, 2008
Last Updated
June 11, 2014
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Rockefeller University, New York Presbyterian Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00594724
Brief Title
Improving Therapeutic Outcomes in the Tongue Carcinoma Patient: Assessment of Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging
Official Title
Improving Therapeutic Outcomes in the Tongue Carcinoma Patient: Assessment of Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Rockefeller University, New York Presbyterian Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tongue Carcinoma
Keywords
Tongue, Carcinoma, Cancer, 02-093
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Determine relationship between mechanisms of adaptation at level of central nervous system to alterations in function in the tongue.
Time Frame
7 years
Title
Determine changes in cortical activity in representation of tongue movement that occur pre and post-treatment.
Time Frame
7 years
Title
Determine the central neural response to direct peripheral rehabilitation strategies.
Time Frame
conclusion of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyung Peck, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan-Kettering Cancer Center
Learn more about this trial
Improving Therapeutic Outcomes in the Tongue Carcinoma Patient: Assessment of Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging
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