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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-18

Study Completion Date

2022-05-19

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.

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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.

Conditions

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Thoracic Spine Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Device feasibility (MRI-guided surgery)

Patients undergo standard of care spine surgery with MRI-based image guidance.

Group Type EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type DEVICE

Undergo MRI-guided surgery

Therapeutic Conventional Surgery

Intervention Type PROCEDURE

Undergo spinal surgery

Interventions

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Magnetic Resonance Imaging

Undergo MRI-guided surgery

Intervention Type DEVICE

Therapeutic Conventional Surgery

Undergo spinal surgery

Intervention Type PROCEDURE

Other Intervention Names

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Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No