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

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ClinicalTrials.gov Identifier: NCT04563806
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : October 12, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
Thoracic Spine Neoplasm Procedure: Magnetic Resonance Imaging Procedure: Therapeutic Conventional Surgery Early Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: A Pilot Study to Evaluate the Safety of MRI Compatible Hardware for Intraoperative MRI-Based Image Guidance for Spinal Procedures
Actual Study Start Date : April 18, 2019
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
Experimental: Device feasibility (MRI-guided surgery)
Patients undergo standard of care spine surgery with MRI-based image guidance.
Procedure: Magnetic Resonance Imaging
Undergo MRI-guided surgery
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR Imaging
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

Procedure: Therapeutic Conventional Surgery
Undergo spinal surgery




Primary Outcome Measures :
  1. Incidence of intraoperative adverse events [ Time Frame: During surgery ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563806


Contacts
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Contact: Claudio E Tatsui 713-792-2400 cetatsui@mdanderson.org

Locations
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United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Claudio E. Tatsui    713-792-2400    cetatui@mdanderson.org   
Principal Investigator: Claudio E. Tatsui         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Claudio E Tatsui M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT04563806    
Other Study ID Numbers: 2017-0663
NCI-2020-03700 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0663 ( Other Identifier: M D Anderson Cancer Center )
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No