CEUS For Intraoperative Spinal Cord Injury
Primary Purpose
Spine Disease, Spinal Stenosis, Spinal Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Definity Perflutren Lipid Microsphere Ultrasound Contrast
Sponsored by
About this trial
This is an interventional diagnostic trial for Spine Disease focused on measuring Contrast Enhanced Ultrasound, CEUS
Eligibility Criteria
Inclusion Criteria:
- Patients consented and scheduled for posterior cervicothoracic decompression surgery with the PI for the diagnosis of cervicothoracic myeloradiculopathy
- Age 18-80
Exclusion Criteria:
- Pregnancy
- Patient's with known hypersensitivity to ultrasound contrast
- Patients with known hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG)
- Patients unable to actively participate in the consent process physically and/or cognitively
- Prior decompression at the intended level of decompression
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Contrast Enhanced Ultrasound Arm
Arm Description
Outcomes
Primary Outcome Measures
Contrast Enhanced Ultrasound to determine changes of blood flow in the spinal cord at the site of decompression.
Use of Contrast Enhanced ultrasound to identify discreet areas of perfusion changes in the spinal cord of subjects that undergo spinal cord decompression.
Secondary Outcome Measures
Correlation of perfusion changes measured by intra-operative Contrast Enhanced Ultrasound with neurologic outcomes measured by serial neurologic exams and functional outcomes (Frankel Grade and Modified Rankin Scale).
To assess whether discreet areas of perfusion changes seen by Contrast Enhanced ultrasound in the spinal cord intraoperatively correlate with the neurologic and functional outcomes of subjects that undergo spinal cord decompression
Full Information
NCT ID
NCT05530798
First Posted
August 30, 2022
Last Updated
July 27, 2023
Sponsor
Medical University of South Carolina
Collaborators
South Carolina Spinal Cord Injury Research Fund
1. Study Identification
Unique Protocol Identification Number
NCT05530798
Brief Title
CEUS For Intraoperative Spinal Cord Injury
Official Title
Contrast Enhanced Ultrasound for The Evaluation of Intraoperative Spinal Cord Injury Following Surgical Decompression of a Chronically Compressed Spinal Cord
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
South Carolina Spinal Cord Injury Research Fund
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Spinal cord injury following posterior decompression in patients suffering from chronic, cervicothoracic spinal cord compression is a known complication with multiple etiologies. Currently, intraoperative neuromonitoring (IONM) remains the gold standard for predicting and preventing post-operative deficits from these procedures. However, there is a paucity in the field of spine surgery for further, non-invasive biomarkers that can help detect and prognosticate the degree of spinal cord injury intraoperatively. Contrast enhanced ultrasound (CEUS) is a radiation free imaging modality that utilizes nanobubble technology to allow for visualization of the macro- and microvascular architecture of soft tissue structures. Despite being currently approved for the use in hepatology and cardiology, it has remained absent from the field of spinal cord injury. The study team aims to evaluate and quantify micro- and macrovascular changes that lead to areas of hyper-perfusion as well as areas of ischemia intraoperatively in patients that undergo elective cervicothoracic posterior decompression for chronic compression. In addition, the study team aims to assess the efficacy of CEUS in detecting microvascular changes that correlate with IONM changes and predicting degree and recovery of post-operative neurologic deficits from intraoperative spinal cord injury. The study team hypothesizes that following decompression, subjects will have detectable levels of microvascular changes causing areas of hypoperfusion and reperfusion injury. Second, the study team hypothesizes that these perfusion changes will correlate with intraoperative neuromonitoring changes and can predict and prognosticate the degree of post-operative neurologic injury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spine Disease, Spinal Stenosis, Spinal Injury, Spinal Cord Diseases, Spinal Cord Injuries, Spinal Cord Compression, Spine Degeneration
Keywords
Contrast Enhanced Ultrasound, CEUS
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Contrast Enhanced Ultrasound Arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Definity Perflutren Lipid Microsphere Ultrasound Contrast
Intervention Description
Before the spinal decompression surgery has started, the study team will inject the ultrasound contrast to visualize the spinal cord prior to decompression of the spinal cord.
After the spinal cord has been decompressed, the study team will inject the ultrasound contrast to visualize the spinal cord directly after decompression of the spinal cord.
Prior to completion and closure of the incision, the study team will once more inject the ultrasound contrast to visualize the spinal cord.
A member of the research team will follow up with study participants within a week of the procedure by phone. The research staff will also review the participants' medical record for up to 360 days after your procedure to collect information on clinical outcomes and any additional treatments, tests or procedures the study participants may have had.
Primary Outcome Measure Information:
Title
Contrast Enhanced Ultrasound to determine changes of blood flow in the spinal cord at the site of decompression.
Description
Use of Contrast Enhanced ultrasound to identify discreet areas of perfusion changes in the spinal cord of subjects that undergo spinal cord decompression.
Time Frame
Intra-operative (Approximately 3 hours)
Secondary Outcome Measure Information:
Title
Correlation of perfusion changes measured by intra-operative Contrast Enhanced Ultrasound with neurologic outcomes measured by serial neurologic exams and functional outcomes (Frankel Grade and Modified Rankin Scale).
Description
To assess whether discreet areas of perfusion changes seen by Contrast Enhanced ultrasound in the spinal cord intraoperatively correlate with the neurologic and functional outcomes of subjects that undergo spinal cord decompression
Time Frame
Clinical Monitoring (12 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients consented and scheduled for posterior cervicothoracic decompression surgery with the PI for the diagnosis of cervicothoracic myeloradiculopathy
Age 18-80
Exclusion Criteria:
Pregnancy
Patient's with known hypersensitivity to ultrasound contrast
Patients with known hypersensitivity to perflutren lipid microsphere or its components, such as polyethylene glycol (PEG)
Patients unable to actively participate in the consent process physically and/or cognitively
Prior decompression at the intended level of decompression
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian F Saway, MD
Phone
8434940234
Email
saway@musc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian F Saway, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stephen Kalhorn, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jessica Barley, PhD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Saway, MD
Phone
843-494-0234
Email
saway@musc.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CEUS For Intraoperative Spinal Cord Injury
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