Trial record 2 of 95 for:    "Tongue cancer"

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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Rockefeller University
New York Presbyterian Hospital
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00594724
First received: January 7, 2008
Last updated: June 12, 2013
Last verified: June 2013
  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

Study Type: Interventional
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

Resource links provided by NLM:


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 ]
  • Determine the central neural response to direct peripheral rehabilitation strategies. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 127
Study Start Date: November 2002
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Rockefeller University
New York Presbyterian Hospital
Investigators
Principal Investigator: Kyung Peck, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00594724     History of Changes
Other Study ID Numbers: 02-093
Study First Received: January 7, 2008
Last Updated: June 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Tongue
Carcinoma
Cancer
02-093

Additional relevant MeSH terms:
Carcinoma
Tongue Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases
Tongue Diseases

ClinicalTrials.gov processed this record on April 17, 2014