Know Cancer

forgot password

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

21 Years
75 Years
Open (Enrolling)
Tongue Carcinoma

Thank you

Trial Information

Improving Therapeutic Outcomes in the Tongue Carcinoma Patient: Assessment of 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

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.

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

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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.

Outcome Time Frame:

7 years

Safety Issue:


Principal Investigator

Kyung Peck, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2002

Completion Date:

November 2013

Related Keywords:

  • Tongue Carcinoma
  • Tongue
  • Carcinoma
  • Cancer
  • 02-093
  • Carcinoma
  • Tongue Neoplasms



Memorial Sloan Kettering Cancer Center New York, New York  10021