CEUS For Intraoperative Spinal Cord Injury

Last updated: November 5, 2024
Sponsor: Medical University of South Carolina
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Spinal Cord Disorders

Spinal Stenosis

Spinal Cord Injuries

Treatment

Definity Perflutren Lipid Microsphere Ultrasound Contrast

Clinical Study ID

NCT05530798
00120959
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients consented and scheduled for posterior cervicothoracic decompression surgerywith the PI for the diagnosis of cervicothoracic myeloradiculopathy

  • Age 18-80

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Patient's with known hypersensitivity to ultrasound contrast

  • Patients with known hypersensitivity to perflutren lipid microsphere or itscomponents, such as polyethylene glycol (PEG)

  • Patients unable to actively participate in the consent process physically and/orcognitively

  • Prior decompression at the intended level of decompression

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Definity Perflutren Lipid Microsphere Ultrasound Contrast
Phase:
Study Start date:
December 01, 2023
Estimated Completion Date:
August 01, 2025

Connect with a study center

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

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