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

Early Phase 1

Terminated

• Conditions: Thoracic Spine Neoplasm
• Interventions: Device: Magnetic Resonance Imaging; Procedure: Therapeutic Conventional Surgery

• Registration Number: NCT04563806
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2019-04-18
• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-09-20
• Study First Posted: 2020-09-24
• Primary Completion: 2022-05-19
• Study Completion: 2022-05-19
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-07
• Last Update Posted: 2022-07-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device feasibility (MRI-guided surgery)	Magnetic Resonance Imaging	Patients undergo standard of care spine surgery with MRI-based image guidance.
Device feasibility (MRI-guided surgery)	Therapeutic Conventional Surgery	Patients undergo standard of care spine surgery with MRI-based image guidance.

Primary Outcome Measures

Name	Time	Method
Incidence of intraoperative adverse events	During surgery	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.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States