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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2015-02277 | Registry Identifier | NCI CTRP |
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The goal of this clinical research study is to learn about the safety and accuracy of using MRI as a guidance system during laser ablation surgery of tumors that have spread to the spine.
Study Visits:
If you agree to take part in this study, before your surgery:
During the Surgery:
You will be positioned lying face down on your stomach during surgery. While you are under anesthesia, an MRI will be used to take images of your spine. This is an intraoperative MRI, meaning that it is performed in a special magnet located inside a specifically designed operating room. These images will be loaded into a computer navigation program and will be used to help the doctor perform surgery.
Markers will also be attached to the skin of your back. These markers are used together with the navigation program and MRI images to record the location of where on your spine the doctor should cut. This recording will be compared to the MRI images.
Your doctor will check the accuracy of this recording in 2 ways:
If there is a difference in the result of these 2 measurements, your doctor will use the result of the first step to check the accuracy of the MRI image.
If there is more than 2 millimeter difference between the visual inspection position and the computer model position, your doctor may decide to do one of the following steps:
On the Day After Surgery:
Follow-Up Visits:
The research staff will call you 3 weeks after surgery to ask about your recovery and you will be asked to answer the same questionnaires as before.
You will return for a follow-up visit after surgery:
Length of Study Participation:
Your participation in the study will be over after your follow-up visit.
You will be taken off study if during surgery the doctor thinks the navigation is not accurate, you are injured related to an inaccurate image guidance, or your surgery is stopped.
This is an investigational study. The MRIs and x-rays on this study are performed using FDA-approved and commercially available methods. The use of MRI as image guidance for spinal surgery is investigational.
Up to 10 participants will be enrolled in this study. All will take part at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI-Based Image Guidance | Experimental | MRI images of the spine taken of anesthetized participant in the operative prone position. These images are exported into a computer navigation program, and used to help the doctor perform surgery. Pain and symptom questionnaires completed at baseline and at follow up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Imaging (MRI) | Procedure | MRI images of the spine taken of anesthetized participant in the operative prone position. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety determined by 0% frequency of intraoperative and perioperative adverse events | Safety of Intraoperative MRI-Based Image Guidance to Perform Laser Ablation of Epidural Metastasis | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of MRI-Based Image Guidance to Perform Laser Ablation of Epidural Metastasis | Navigation considered inaccurate if there is a discrepancy of more than 2mm between the real position of the probe confirmed by direct visual inspection, and the computer model displayed on the navigation screen. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio E. Tatsui, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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| ID | Term |
|---|---|
| D013120 | Spinal Cord Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
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| Questionnaires | Behavioral | Pain and symptom questionnaires completed at baseline and at follow up. |
|
|
| D013118 |
| Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |