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

Thoracic Spine Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04563806
• Other study ID #: 2017-0663
• Secondary ID: NCI-2020-0370020
• Status: Terminated
• Phase: Early Phase 1
• Start date: April 18, 2019
• Est. completion date: May 19, 2022

Study information

• Verified date: July 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: May 19, 2022
• Est. primary completion date: May 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thoracic Spine Neoplasm

Intervention

Device:
• Magnetic Resonance Imaging
Undergo MRI-guided surgery

Procedure:
• Therapeutic Conventional Surgery
Undergo spinal surgery

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M D Anderson Cancer Center