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

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

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04563806

Enrollment

Registered

2020-09-24

Start date

2019-04-18

Completion date

2022-05-19

Last updated

2022-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Spine Neoplasm

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.

Interventions

DEVICEMagnetic Resonance Imaging

Undergo MRI-guided surgery

PROCEDURETherapeutic Conventional Surgery

Undergo spinal surgery

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026