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

Spinal Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02613390
• Other study ID #: 2015-0481
• Secondary ID: NCI-2015-02277
• Status: Completed
• Phase: N/A
• Start date: December 18, 2015
• Est. completion date: October 17, 2018

Study information

• Verified date: January 2019
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: October 17, 2018
• Est. primary completion date: October 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Spinal Cord Neoplasms
• Spinal Neoplasms
• Spinal Tumor

Intervention

Procedure:
• Magnetic Resonance Imaging (MRI)
MRI images of the spine taken of anesthetized participant in the operative prone position.

Behavioral:
• Questionnaires
Pain and symptom questionnaires completed at baseline and at follow up.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety determined by 0% frequency of intraoperative and perioperative adverse events	Safety of Intraoperative MRI-Based Image Guidance to Perform Laser Ablation of Epidural Metastasis	3 weeks
Secondary	Accuracy of MRI-Based Image Guidance to Perform Laser Ablation of Epidural Metastasis	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

External Links

•   University of Texas MD Anderson Cancer Center Website