Safety of MRI Compatible Hardware for MRI-based Image Guidance During Spine Surgery

Study Overview
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Brief Summary
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This trial investigates the safety and accuracy of using 2 pieces of hardware (a clamp and a needle) that are able to be used with magnetic resonance imaging (MRI) during spinal surgery. During a standard spinal surgery, a computed tomography (CT) scan is used to help plan the placement of surgical instruments used during the procedure or for needle biopsies. Then, the patient is moved to the MRI. For this study, the patient is able to stay in place as the hardware used in this study is able to work with the MRI. Using MRI compatible hardware may allow for an extra degree of safety and facilitate better surgical workflow.

Detailed Description
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PRIMARY OBJECTIVE: I. To document the safety of utilizing MRI compatible hardware for intraoperative MRI-based image guidance to perform percutaneous spinal procedures. SECONDARY OBJECTIVE: I. To determine the accuracy of the MRI-based image guidance. OUTLINE: Patients undergo standard of care spine surgery with MRI-based image guidance.

Official Title
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A Pilot Study to Evaluate the Safety of MRI Compatible Hardware for Intraoperative MRI-Based Image Guidance for Spinal Procedures

Conditions
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Thoracic Spine Neoplasm

Intervention / Treatment
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* Device: Magnetic Resonance Imaging
* Procedure: Therapeutic Conventional Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing percutaneous spinal procedures requiring image guidance at MD Anderson Age > 18 years old. (The indication for this technique is controversial in skeletally immature patients.) All diagnoses are eligible Vertebral body site to be treated located from T2 to T12 Signed informed consent Exclusion Criteria: Requires open spinal procedure or a percutaneous procedure without the use of image guidance Unable to tolerate general anesthesia and prone position Unable to undergo MRI scan of the spine

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device feasibility (MRI-guided surgery)<br>Patients undergo standard of care spine surgery with MRI-based image guidance. | Device: Magnetic Resonance Imaging<br>* Undergo MRI-guided surgery<br>* Other names: Nuclear Magnetic Resonance Imaging;Procedure: Therapeutic Conventional Surgery<br>* Undergo spinal surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of intraoperative adverse events | Safety will be assessed as a dichotomous variable. Frequencies and descriptive statistics of the outcomes under study will be performed. 95% confidence intervals will be computed. Other ad-hoc analyses may be performed as well. | During surgery |