Safety Evaluation of Intra-Operative MRI-Based Guidance for Laser Ablation of Epidural Metastasis

January 8, 2019 updated by: M.D. Anderson Cancer Center

A Pilot Study to Evaluate Safety of Intraoperative MRI-Based Image Guidance for Laser Ablation of Epidural Metastasis

The goal of this clinical research study is to learn about the safety and accuracy of using MRI as a guidance system during laser ablation surgery of tumors that have spread to the spine.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Visits:

If you agree to take part in this study, before your surgery:

  • You will have a physical exam.
  • You will have a neurological exam (tests to check the functioning of your nerves, including tests of your balance and reflexes).
  • You will complete questionnaires about pain and other symptoms that should take about 10-15 minutes.
  • You will sign a separate consent for your spinal surgery that explains the risks.

During the Surgery:

You will be positioned lying face down on your stomach during surgery. While you are under anesthesia, an MRI will be used to take images of your spine. This is an intraoperative MRI, meaning that it is performed in a special magnet located inside a specifically designed operating room. These images will be loaded into a computer navigation program and will be used to help the doctor perform surgery.

Markers will also be attached to the skin of your back. These markers are used together with the navigation program and MRI images to record the location of where on your spine the doctor should cut. This recording will be compared to the MRI images.

Your doctor will check the accuracy of this recording in 2 ways:

  • Placing the tip of the navigation probe on your skin and comparing it with the computer calculation in the computer navigation program. This is a standard navigation probe commonly used in spinal surgeries.
  • Inserting the navigation probe through a small cut on your skin along the surgical area and taking an x-ray image of its location.

If there is a difference in the result of these 2 measurements, your doctor will use the result of the first step to check the accuracy of the MRI image.

If there is more than 2 millimeter difference between the visual inspection position and the computer model position, your doctor may decide to do one of the following steps:

  • Restart the recording process by getting a new MRI image
  • Use only the x-ray images to complete the procedure
  • Stop the surgery

On the Day After Surgery:

  • You will have a physical exam.
  • You will have a neurological exam.
  • You will complete the same questionnaires as before.

Follow-Up Visits:

The research staff will call you 3 weeks after surgery to ask about your recovery and you will be asked to answer the same questionnaires as before.

You will return for a follow-up visit after surgery:

  • You will have a physical exam.
  • You will have a neurological exam.
  • You will complete the same questionnaires as before.

Length of Study Participation:

Your participation in the study will be over after your follow-up visit.

You will be taken off study if during surgery the doctor thinks the navigation is not accurate, you are injured related to an inaccurate image guidance, or your surgery is stopped.

This is an investigational study. The MRIs and x-rays on this study are performed using FDA-approved and commercially available methods. The use of MRI as image guidance for spinal surgery is investigational.

Up to 10 participants will be enrolled in this study. All will take part at MD Anderson.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age =/> 18 years old.
  2. Must have epidural metastasis to be treated with MRI-guided laser ablation.
  3. Vertebral body site to be treated is located from C3 to L5.
  4. Signed informed consent.

Exclusion Criteria:

  1. Requires open spinal procedure or a percutaneous procedure without the use of image guidance.
  2. Unable to tolerate general anesthesia and prone position.
  3. Unable to undergo MRI of the spine.
  4. Pregnant female.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI-Based Image Guidance

MRI images of the spine taken of anesthetized participant in the operative prone position. These images are exported into a computer navigation program, and used to help the doctor perform surgery.

Pain and symptom questionnaires completed at baseline and at follow up.
Procedure: Magnetic Resonance Imaging (MRI)
MRI images of the spine taken of anesthetized participant in the operative prone position.
Other Names:
  • MRI
Behavioral: Questionnaires
Pain and symptom questionnaires completed at baseline and at follow up.
Other Names:
  • Surveys

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety determined by 0% frequency of intraoperative and perioperative adverse events
Time Frame: 3 weeks
Safety of Intraoperative MRI-Based Image Guidance to Perform Laser Ablation of Epidural Metastasis
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of MRI-Based Image Guidance to Perform Laser Ablation of Epidural Metastasis
Time Frame: 1 day
Navigation considered inaccurate if there is a discrepancy of more than 2mm between the real position of the probe confirmed by direct visual inspection, and the computer model displayed on the navigation screen.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Claudio E. Tatsui, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2015

Primary Completion (Actual)

October 17, 2018

Study Completion (Actual)

October 17, 2018

Study Registration Dates

First Submitted

November 20, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimate)

November 24, 2015

Study Record Updates

Last Update Posted (Actual)

January 10, 2019

Last Update Submitted That Met QC Criteria

January 8, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0481
  • NCI-2015-02277 (Registry Identifier: NCI CTRP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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