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NCT01534104 · ClinicalTrials.gov registry record · NA
MRI and Diffusion Imaging of Eloquent Brain Areas to Optimize Brain Tumor Resection Planning
A NA study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 145
- Enrollment target
NCT01534104: Completed NA study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01534104 is a NA study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 145 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01534104, a NA study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 145 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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.
Interventions
- PROCEDURE preoperative fMRI. DTI and DSI with tractography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2012-02 |
| Est. Completion | 2023-06-08 |
| Phase | NA |
What the finished NCT01534104 record still lists
NCT01534104 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which preoperative fMRI. DTI and DSI with tractography is the first listed.
NCT01534104 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01534104 about?
NCT01534104 is a clinical study titled "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 ...
What is the current status of trial NCT01534104?
This trial is currently completed. It is a NA study. The enrollment target is 145 participants. The study started on 2012-02. Estimated completion is 2023-06-08.
What interventions are being tested in trial NCT01534104?
The interventions under investigation include: preoperative fMRI. DTI and DSI with tractography (PROCEDURE).
Who is sponsoring clinical trial NCT01534104?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01534104's enrollment target sits among peer trials
145 705th of 2000 higher than 1,295 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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