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

NCT04563806 | Terminated Early Phase 1

• 2 other identifiers: 2017-0663NCI-2020-03700
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Thoracic Spine Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Device feasibility (MRI-guided surgery)

EXPERIMENTAL

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

Device: Magnetic Resonance Imaging; Procedure: Therapeutic Conventional Surgery

Interventions

Magnetic Resonance Imaging DEVICE

Undergo MRI-guided surgery

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Device feasibility (MRI-guided surgery)

Therapeutic Conventional Surgery PROCEDURE

Undergo spinal surgery

Device feasibility (MRI-guided surgery)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Claudio E Tatsui

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2020
• First Posted: September 24, 2020
• Study Start: April 18, 2019
• Primary Completion: May 19, 2022
• Study Completion: May 19, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Locations

US (1)