Spinal Tumor Clinical Trial
Official title:
A Pilot Study to Evaluate Safety of Intraoperative MRI-Based Image Guidance for Laser Ablation of Epidural Metastasis
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:
- You will have a physical exam.
- You will have a neurological exam (tests to check the functioning of your nerves,
including tests of your balance and reflexes).
- You will complete questionnaires about pain and other symptoms that should take about
10-15 minutes.
- You will sign a separate consent for your spinal surgery that explains the risks.
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:
- Placing the tip of the navigation probe on your skin and comparing it with the computer
calculation in the computer navigation program. This is a standard navigation probe
commonly used in spinal surgeries.
- Inserting the navigation probe through a small cut on your skin along the surgical area
and taking an x-ray image of its location.
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:
- Restart the recording process by getting a new MRI image
- Use only the x-ray images to complete the procedure
- Stop the surgery
On the Day After Surgery:
- You will have a physical exam.
- You will have a neurological exam.
- You will complete the same questionnaires as before.
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:
- You will have a physical exam.
- You will have a neurological exam.
- You will complete the same questionnaires as before.
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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