Language Function in Patients With Brain Tumors - Full Text View

Sponsored by:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00599703

Purpose

The purpose of this study is to use an imaging method called functional magnetic resonance imaging (fMRI) in patients who have a tumor near an area of the brain that is believed to control language. The fMRI is a new kind of imaging that uses a strong magnetic field to look at functioning brain tissue. This kind of imaging will be used to study the effect of the brain tumor on your speech.

Condition	Intervention
Brain Cancer CNS Cancer	Other: fMRI Scan, pre- and post language evaluation

MedlinePlus related topics: Brain Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Reorganization of Language Function in Patients With Brain Tumors

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

Primary Outcome Measures:

To identify language organization prior to surgery in patients in whom a tumor invades or is directly adjacent to the expected location of one of the language centers. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess language reorganization over time. [ Time Frame: conclusion of study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	May 2005
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 neurosurgical patients	Other: fMRI Scan, pre- and post language evaluation All subjects will undergo functional MR imaging, pre- and post-surgical language evaluation, and electrocortical stimulation mapping. The brain tumor patients will undergo these procedures twice.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

MSKCC clinics

Criteria

Inclusion Criteria:

Patient in whom a tumor invades or is directly adjacent to the expected location of one of the language centers.
At least 18 years of age
English as first language

Exclusion Criteria:

Patients with high grade tumors
History of significant psychiatric condition (e.g. schizophrenia, obsessive-compulsive disorder, significant dementia),
History of the following neurological conditions: CVA, demyelinating conditions, cerebral palsy, Alzheimer's disease.
History of significant claustrophobic reactions.
Pregnancy
Standard contraindications to MR examinations (e.g. implanted stimulator)
Patients, who were treated prior to our first scan, will not be eligible to participate in this study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599703

Contacts

Contact: Andrei Holodny, MD		holodnya@mskcc.org
Contact: Kyung Peck, PhD		peckk@mskcc.org

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Andrei Holodny, MD holodnya@mskcc.org
Contact: Kyung Peck, PhD peckk@mskcc.org
Principal Investigator: Andrei Holodny, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Andrei Holodny, 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 ( Andrei Holodny, M.D. )
Study ID Numbers:	05-043
Study First Received:	January 11, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00599703
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Brain Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009