NCT05530798

CEUS For Intraoperative Spinal Cord Injury

Completed NA Last updated 27 August 2025

What this trial tests

NA trial testing Definity Perflutren Lipid Microsphere Ultrasound Contrast in Spine Disease in 20 participants. Completed in 1 August 2025.

Timeline

1 December 2023

Primary endpoint
1 August 2025

1 August 2025

Quick facts

Lead sponsor	Medical University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	20
Start date	1 December 2023
Primary completion	1 August 2025
Estimated completion	1 August 2025
Sites	1 location across United States

Drugs / interventions tested

• Definity Perflutren Lipid Microsphere Ultrasound Contrast

Conditions studied

• Spine Disease — all drugs for Spine Disease →
• Spinal Stenosis — all drugs for Spinal Stenosis →
• Spinal Injury — all drugs for Spinal Injury →
• Spinal Cord Diseases — all drugs for Spinal Cord Diseases →

Sponsor

Medical University of South Carolina

Who can join

Adults 18 to 80, any sex, with Spine Disease or Spinal Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bubble-Based Drug Delivery Systems: Next-Generation Diagnosis to Therapy.
   Kancheva M, Aronson L, Pattilachan T, Sautto F, et al · · 2023 · cited 16× · PMID 37504868 · DOI 10.3390/jfb14070373
2. NanoBubble-Mediated Oxygenation: Elucidating the Underlying Molecular Mechanisms in Hypoxia and Mitochondrial-Related Pathologies.
   Viafara Garcia SM, Khan MS, Haidar ZS, Acevedo Cox JP. · · 2023 · cited 13× · PMID 38063756 · DOI 10.3390/nano13233060
3. NanoBubble-mediated Oxygenation: Elucidating the Underlying Molecular Mechanisms in Hypoxia and Mitochondrial-related Pathologies
   Viafara-Garcia SM, Khan MS, Haidar ZS, Acevedo Cox JP. · · 2023 · DOI 10.20944/preprints202310.0962.v1