Brain CancerNCT00599703
Language Function in Patients With Brain Tumors
An observational study of Brain Cancer and CNS Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer, CNS Cancer
- What is being tested?
- fMRI Scan, pre- and post language evaluation
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2005to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MSKCC clinics
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Reorganization of Language Function in Patients With Brain Tumors
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.
- Conditions
- Brain Cancer, CNS Cancer
- Being tested
- fMRI Scan, pre- and post language evaluation
- Medical subject headings
- Brain Neoplasms, Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI Scan, pre- and post language evaluationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | neurosurgical patients Receives: Other: fMRI Scan, pre- and post language evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: conclusion of study
Secondary outcomes (1)
To assess language reorganization over time.
Measured: conclusion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2008 (estimated)
- Study startMay 2005
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Andrei Holodny, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00599703
- Sponsor's protocol ID
- 05-043
- Status last verified
- Jul 2009
- First submitted
- 11 Jan 2008
- Last updated
- 8 Jul 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reorganization of Language Function in Patients With Brain Tumors
- ClinicalTrials.gov ID
- NCT00599703
- Acronym / sponsor ID
- 05-043
- Conditions
- Brain Cancer, CNS Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- May 2005
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 24 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: fMRI Scan, pre- and post language evaluationneurosurgical patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MSKCC clinics
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI Scan, pre- and post language evaluationAll 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. | Other | 1 |
Primary outcome
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
1 secondary outcome
To assess language reorganization over time.
Time frame: conclusion of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2009.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Holodny, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Cancer and CNS Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2009.