An interventional study of Magnetic Resonance Imaging (MRI) and Questionnaires in Spinal Tumor, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-10.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Diagnostic
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.
Exclusion Criteria:
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.
Procedure: Magnetic Resonance Imaging (MRI) · Behavioral: Questionnaires
MRI images of the spine taken of anesthetized participant in the operative prone position.
Also known as: MRI
Pain and symptom questionnaires completed at baseline and at follow up.
Also known as: Surveys
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
Time frame: 3 weeks
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.
Time frame: 1 day
This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center