NCT00599703

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 24, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

July 8, 2009

Status Verified

July 1, 2009

Enrollment Period

3.8 years

First QC Date

January 11, 2008

Last Update Submit

July 7, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • To assess language reorganization over time.

    conclusion of study

Study Arms (1)

1

neurosurgical patients

Other: fMRI Scan, pre- and post language evaluation

Interventions

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MSKCC clinics

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Brain NeoplasmsCentral Nervous System Neoplasms

Interventions

Lead

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Metals, HeavyElementsInorganic ChemicalsMetals

Study Officials

  • Andrei Holodny, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2008

First Posted

January 24, 2008

Study Start

May 1, 2005

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

July 8, 2009

Record last verified: 2009-07

Locations