CEUS For Intraoperative Spinal Cord Injury

Contrast Enhanced Ultrasound for The Evaluation of Intraoperative Spinal Cord Injury Following Surgical Decompression of a Chronically Compressed Spinal Cord

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Diseases; Spinal Stenosis; Spinal Cord Injuries; Spine Degeneration; Spinal Cord Compression; Spine Disease; Spinal Injury
• Intervention / Treatment: Device: Definity Perflutren Lipid Microsphere Ultrasound Contrast

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian F Saway, MD; Phone Number: 8434940234; Email: saway@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Brian Saway, MD; Phone Number: 843-494-0234; Email: saway@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Contrast Enhanced Ultrasound Arm

Device: Definity Perflutren Lipid Microsphere Ultrasound Contrast; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intra-operative (Approximately 3 hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Clinical Monitoring (12 months)

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: South Carolina Spinal Cord Injury Research Fund
• Investigators: Principal Investigator: Brian F Saway, MD, Medical University of South Carolina; Principal Investigator: Stephen Kalhorn, MD, Medical University of South Carolina; Principal Investigator: Jessica Barley, PhD, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: CEUS; Contrast Enhanced Ultrasound
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Musculoskeletal Diseases; Trauma, Nervous System; Bone Diseases; Back Injuries; Wounds and Injuries; Spinal Cord Diseases; Spinal Diseases; Spinal Stenosis; Spinal Cord Injuries; Spinal Injuries; Spinal Cord Compression
• Other Study ID Numbers: 00120959

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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