Improving Therapeutic Outcomes in the Tongue Carcinoma Patient: Assessment of Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center Rockefeller University New York Presbyterian Hospital
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00594724

Purpose

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.

Condition	Intervention
Tongue Carcinoma	Procedure: MRI

MedlinePlus related topics: Cancer MRI Scans

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment
Official Title:	Improving Therapeutic Outcomes in the Tongue Carcinoma Patient: Assessment of Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

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. [ Time Frame: 7 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	127
Study Start Date:	November 2002
Estimated Study Completion Date:	November 2010
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Procedure: MRI Adaptation Using Functional Magnetic Resonance Imaging and Diffusion Tensor Imaging

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.

Eligibility

Ages Eligible for Study:	21 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00594724

Contacts

Contact: Dennis Kraus, MD

krausd@mskcc.org

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Principal Investigator: Dennis Kraus, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Rockefeller University

New York Presbyterian Hospital

Investigators

Principal Investigator:

Dennis Kraus, MD

Memorial Sloan-Kettering Cancer Center

More Information

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Kraus, Dennis, MD )
Study ID Numbers:	02-093
Study First Received:	January 7, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00594724
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Tongue
Carcinoma
Cancer

Study placed in the following topic categories:

Mouth Diseases
Tongue Neoplasms
Tongue neoplasm
Oral cancer
Head and Neck Neoplasms

Stomatognathic Diseases
Mouth Neoplasms
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Tongue Diseases

ClinicalTrials.gov processed this record on January 16, 2009