Language Function in Patients With Brain Tumors | NCT00599703

Studies
Language Function in Patients With Brain Tumors

NCT00599703

Sponsor

Memorial Sloan Kettering Cancer Center

Status

Completed

Last Update Posted

Jul 8, 2009Estimated

Enrollment

7Actual

Phase

Not provided

Conditions

Brain Cancer
CNS Cancer

Interventions

fMRI Scan, pre- and post language evaluation

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2005

Primary Completion Date

Mar 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Jan 11, 2008

First Submission Date that Met QC Criteria

Jan 11, 2008

First Posted Date

Jan 24, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2009

Last Update Posted Date

Jul 8, 2009Estimated

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		neurosurgical patients	Other: fMRI Scan, pre- and post language evaluation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
fMRI Scan, pre- and post language evaluation	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.		conclusion of study

Secondary Outcomes

Measure	Description	Time Frame
To assess language reorganization over time.		conclusion of study

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

MSKCC clinics

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrei Holodny, MD	Memorial Sloan Kettering Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan Kettering Cancer Center		New York	New York	10065	United States

Label	URL
Memorial Sloan-Kettering Cancer Center	View source

Condition Browse Module

MeSH Terms

ID	Term
D001932	Brain Neoplasms
D016543	Central Nervous System Neoplasms

Ancestor Terms

ID	Term
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007854	Lead

Ancestor Terms

ID	Term
D019216	Metals, Heavy
D004602	Elements
D007287	Inorganic Chemicals
D008670	Metals

Browse Leaves

Not provided

Browse Branches

Not provided