Safety of MRI Compatible Hardware for MRI-based Image Gui... | NCT04563806

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

NCT04563806

Sponsor

M.D. Anderson Cancer Center

Status

Terminated

Last Update Posted

Jul 11, 2022Actual

Enrollment

16Actual

Phase

Early Phase 1

Conditions

Thoracic Spine Neoplasm

Interventions

Magnetic Resonance Imaging
Therapeutic Conventional Surgery

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2020-03700	Registry Identifier	CTRP (Clinical Trial Reporting Program)
2017-0663	Other Identifier	M D Anderson Cancer Center

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Per PI

Expanded Access Info

Start Date

Apr 18, 2019Actual

Primary Completion Date

May 19, 2022Actual

Completion Date

May 19, 2022Actual

First Submitted Date

Jun 10, 2020

First Submission Date that Met QC Criteria

Sep 20, 2020

First Posted Date

Sep 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2022

Last Update Posted Date

Jul 11, 2022Actual

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Magnetic Resonance Imaging	Device	Undergo MRI-guided surgery	Device feasibility (MRI-guided surgery)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Claudio E Tatsui	M.D. Anderson Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
M D Anderson Cancer Center		Houston	Texas	77030	United States

Label	URL
M D Anderson Cancer Center	View source

Intervention Browse Module

MeSH Terms

ID	Term
D008279	Magnetic Resonance Imaging

Ancestor Terms

ID	Term
D014054	Tomography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

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Browse Branches

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