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

NCT02613390 | Completed

• 2 other identifiers: 2015-0481NCI-2015-02277
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Tumor

Keywords

Epidural metastasis; Magnetic resonance imaging; MRI; Guidance system; Spinal surgery; Questionnaires; Surveys

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Accuracy of MRI-Based Image Guidance to Perform Laser Ablation of Epidural Metastasis

  1 day

Study Arms (1)

MRI-Based Image Guidance

EXPERIMENTAL

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); Behavioral: Questionnaires

Interventions

Magnetic Resonance Imaging (MRI) PROCEDURE

MRI images of the spine taken of anesthetized participant in the operative prone position.

Also known as: MRI

MRI-Based Image Guidance

Questionnaires BEHAVIORAL

Pain and symptom questionnaires completed at baseline and at follow up.

Also known as: Surveys

MRI-Based Image Guidance

Eligibility Criteria

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

You may qualify if:

• Age =/\> 18 years old.
• Must have epidural metastasis to be treated with MRI-guided laser ablation.
• Vertebral body site to be treated is located from C3 to L5.
• 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 of the spine.
• Pregnant female.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Spinal Cord Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Claudio E. Tatsui, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 24, 2015
• Study Start: December 18, 2015
• Primary Completion: October 17, 2018
• Study Completion: October 17, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

US (1)