Brain CancerNCT01534104
MRI and Diffusion Imaging of Eloquent Brain Areas to Optimize Brain Tumor Resection Planning
A study testing preoperative fMRI. DTI and DSI with tractography in people with Brain Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
Many patients with brain tumors require surgery. Some patients have brain tumors near important parts of the brain. These brain areas have roles in language or motor function. Avoiding these motor and language areas helps to prevent neurological deficits. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer
- What is being tested?
- preoperative fMRI. DTI and DSI with tractography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to 8 Jun 2023
- Phase
- Interventional
- 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
Who may be able to join
- Primary or secondary brain tumor (enhancing mass lesion ± nonenhancing abnormality), known or suspected, located near (< 2 cm) any portion of the motor cortex, motor pathway, language cortex, or language pathway as determined on anatomical images;
- Planned resection of the tumor;
- fMRI and/or DTI required for preoperative imaging as part of the standard of care
- Patient and/or guardian is able to provide written informed consent prior to study registration
- Age ≥ 18 years old
Who cannot join
- Unable to tolerate MRI and/or perform fMRI tasks (e.g., severe claustrophobia or pacemaker or aneurysm clip that precludes MRI scan)
- Pregnant or nursing female
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: Using Functional MRI and Diffusion Imaging of Eloquent Brain Areas to Optimize Brain Tumor Resection Planning
Many patients with brain tumors require surgery. Some patients have brain tumors near important parts of the brain. These brain areas have roles in language or motor function. Avoiding these motor and language areas helps to prevent neurological deficits. The investigators are studying the parts of the brain involved in motor and language. Patients usually get functional MRI (fMRI) or resting-state fMRI (rs-fMRI) for gray matter mapping and diffusion tensor imaging (DTI) or diffusion spectrum imaging (DSI) for white matter mapping. These special MRI sequences are used to plan surgery. Patients are scheduled to have imaging to help plan for possible surgery.
Some patients may require stimulation during surgery to motor and language areas. In patients who require stimulation as part of their standard of care, the investigators will compare the investigators imaging results with the stimulation results. The purpose of this study is to improve MRI mapping of the motor and language pathways in the brain.
Read more
The scans are necessary stimulation for this protocol are part of the standard of care. In other words, these tests are done as part of the best possible care even if they did not join this study. The investigators are studying new techniques for analyzing the MRI data. These new techniques may give the doctor a better view of where the brain tumor is located relative to important parts of the brain.
The investigators will only perform the test sequences that are necessary for mapping the tumor. Most patients will require both fMRI and DTI. Some patients may only require fMRI or DTI. The investigators may also ask to perform optional sequences during the scan. Multi-echo is an modified form of fMRI. DSI is a modified form of DTI. These optional sequences are for research only. The patient would not get these sequences if they do not enroll in this study.
- Conditions
- Brain Cancer
- Being tested
- preoperative fMRI. DTI and DSI with tractography
- Keywords
- fMRI, DTI, DSI, tractography, neurological/physical testing, Motor and Language Pathways, resting state fMRI, 12-008
- Medical subject headings
- Brain Neoplasms, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative fMRI. DTI and DSI with tractographyProcedure or surgery
W/I approx 4-6 weeks of the fMRI, DTI \& DSI, neurological/physical testing \& brain MRI showing tumor \&/or edema located in or near (<2 cm) the motor cortex (precentral gyrus), motor pathway (corticospinal tract), language cortex (Broca's area, Wernicke's area), \&/or language pathway (arcuate fasciculus) Preoperative MRI for surgical planning (approximately <48 hours before surgery*) fMRI to localize gray matter DTI, DSI \& tractography to localize white matter, DSI \& updated fMRI (Optional) Most patients will undergo surgery w/i 48 hrs of their preoperative MRI. For some patients, the MRI results will be used for preoperative counseling. In this subset of patients, we expect that surgery will occur w/i 3-4 months of the MRI. Brain tumor resection as per the treating neurosurgeon Electrical stimulation to localize gray \&/or white matter structures if clinically necessary according to the standard of care at MSKCC Postoperative neurological/physical examination (<48 hours after surgery)
| Study group | Role | What they receive |
|---|---|---|
| pts who have primary or secondary brain tumors | Experimental | The study will prospectively enroll subjects who have primary or secondary brain tumors located near the motor pathway (corticospinal tract) or language pathway (arcuate fasciculus). This is a nonrandomized study in which each subject will receive the standard of care as per the treating neurosurgeon. Receives: Procedure: preoperative fMRI. DTI and DSI with tractography |
What is being measured
The primary outcome is the main question the study is designed to answer.
standard vs. probabilistic tractography
The standard and probabilistic tractography results will be compared to expected anatomy as determined by expert operators. The reconstructed tracts will be examined for their configurations near the tumor and/or edema, and the completeness of their courses. All analyses will be scored by two expert operators (2 board certified radiologists who hold Certificates of Added Qualification in Neuroradiology and are familiar with DTI and tractography), with disagreements resolved by consensus.
Measured: 1 year
Secondary outcomes (2)
the utility of diffusion spectrum imaging (DSI)
(Optional) DSI is a newly proposed modification of DTI that allows potentially improved visualization of the complex white matter architecture. Recent technical advances have allowed marked reduction of the DSI scan time to match other clinical scan times. DSI in brain tumor patients has not been described Analysis of the DSI results will be performed in a manner similar to the analysis for DTI in Specific Aim #1. Briefly, the endings of the rostral language tracts will be graded as: 0-none; 1-few; 2-some; or 3-all for tracts extending to the fMRI activated Broca's area. Both motor and language tracts will be compared to the contralateral mirror tract using a similar 0-3 scale (0-absent, 3-normal) by two expert operators with disagreements resolved by consensus.
Measured: 2 years
feasibility of updated fMRI sequences
(Optional) rs-fMRI is a newly proposed technique to map functional networks in the brain with data obtained during a quiet, resting state condition - as opposed to the usual task-based fMRI that requires patient cooperation and performance. This is an exploratory aim and no statistical analyses are expected to be performed. We anticipate that all of the patients who undergo rs-fMRI will be able to lie still for the additional approximate 7 min required to acquire the updated fMRI sequence.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Responsible party
- Sponsor
- Investigators
- Robert Young, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01534104
- Sponsor's protocol ID
- 12-008
- Status last verified
- Jun 2023
- First submitted
- 9 Feb 2012
- Last updated
- 9 Jun 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Functional MRI and Diffusion Imaging of Eloquent Brain Areas to Optimize Brain Tumor Resection Planning
- ClinicalTrials.gov ID
- NCT01534104
- Acronym / sponsor ID
- 12-008
- Conditions
- Brain Cancer
- Keywords
- fMRI, DTI, DSI, tractography, neurological/physical testing, Motor and Language Pathways, resting state fMRI, 12-008
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Weill Medical College of Cornell University
- Study start
- Feb 2012 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 16 Feb 2012 (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.
Many patients with brain tumors require surgery. Some patients have brain tumors near important parts of the brain. These brain areas have roles in language or motor function. Avoiding these motor and language areas helps to prevent neurological deficits. The investigators are studying the parts of the brain involved in motor and language. Patients usually get functional MRI (fMRI) or resting-state fMRI (rs-fMRI) for gray matter mapping and diffusion tensor imaging (DTI) or diffusion spectrum imaging (DSI) for white matter mapping. These special MRI sequences are used to plan surgery. Patients are scheduled to have imaging to help plan for possible surgery.
Some patients may require stimulation during surgery to motor and language areas. In patients who require stimulation as part of their standard of care, the investigators will compare the investigators imaging results with the stimulation results. The purpose of this study is to improve MRI mapping of the motor and language pathways in the brain.
The scans are necessary stimulation for this protocol are part of the standard of care. In other words, these tests are done as part of the best possible care even if they did not join this study. The investigators are studying new techniques for analyzing the MRI data. These new techniques may give the doctor a better view of where the brain tumor is located relative to important parts of the brain.
The investigators will only perform the test sequences that are necessary for mapping the tumor. Most patients will require both fMRI and DTI. Some patients may only require fMRI or DTI. The investigators may also ask to perform optional sequences during the scan. Multi-echo is an modified form of fMRI. DSI is a modified form of DTI. These optional sequences are for research only. The patient would not get these sequences if they do not enroll in this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pts who have primary or secondary brain tumors | Experimental | Procedure: preoperative fMRI. DTI and DSI with tractographyThe study will prospectively enroll subjects who have primary or secondary brain tumors located near the motor pathway (corticospinal tract) or language pathway (arcuate fasciculus). This is a nonrandomized study in which each subject will receive the standard of care as per the treating neurosurgeon. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Primary or secondary brain tumor (enhancing mass lesion ± nonenhancing abnormality), known or suspected, located near (< 2 cm) any portion of the motor cortex, motor pathway, language cortex, or language pathway as determined on anatomical images;
- Planned resection of the tumor;
- fMRI and/or DTI required for preoperative imaging as part of the standard of care
- Patient and/or guardian is able to provide written informed consent prior to study registration
- Age ≥ 18 years old
Key exclusion criteria (2 listed)
- Unable to tolerate MRI and/or perform fMRI tasks (e.g., severe claustrophobia or pacemaker or aneurysm clip that precludes MRI scan)
- Pregnant or nursing female
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 |
|---|---|---|
| preoperative fMRI. DTI and DSI with tractographyW/I approx 4-6 weeks of the fMRI, DTI \& DSI, neurological/physical testing \& brain MRI showing tumor \&/or edema located in or near (<2 cm) the motor cortex (precentral gyrus), motor pathway (corticospinal tract), language cortex (Broca's area, Wernicke's area), \&/or language pathway (arcuate fasciculus) Preoperative MRI for surgical planning (approximately <48 hours before surgery*) fMRI to localize gray matter DTI, DSI \& tractography to localize white matter, DSI \& updated fMRI (Optional) Most patients will undergo surgery w/i 48 hrs of their preoperative MRI. For some patients, the MRI results will be used for preoperative counseling. In this subset of patients, we expect that surgery will occur w/i 3-4 months of the MRI. Brain tumor resection as per the treating neurosurgeon Electrical stimulation to localize gray \&/or white matter structures if clinically necessary according to the standard of care at MSKCC Postoperative neurological/physical examination (<48 hours after surgery) | Procedure or surgery | pts who have primary or secondary brain tumors |
Primary outcome
standard vs. probabilistic tractography
Time frame: 1 year
The standard and probabilistic tractography results will be compared to expected anatomy as determined by expert operators. The reconstructed tracts will be examined for their configurations near the tumor and/or edema, and the completeness of their courses. All analyses will be scored by two expert operators (2 board certified radiologists who hold Certificates of Added Qualification in Neuroradiology and are familiar with DTI and tractography), with disagreements resolved by consensus.
2 secondary outcomes
the utility of diffusion spectrum imaging (DSI)
Time frame: 2 years
feasibility of updated fMRI sequences
Time frame: 2 years
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 9 Jun 2023.
- 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.
Robert Young, 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?
A study testing preoperative fMRI. DTI and DSI with tractography in people with Brain 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 5 inclusion and 2 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 9 Jun 2023. 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?
standard vs. probabilistic tractography (time frame: 1 year). 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 9 Jun 2023; AzTrials last refreshed its copy on 6 Nov 2026.