An interventional study of Definity Perflutren Lipid Microsphere Ultrasound Contrast in Spine Disease, Spinal Stenosis and Spinal Injury, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Diagnostic
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.
458 studies on the registry are indexed under Spinal Stenosis; 105 are open to participants now.
This study's enrollment of 20 is below the median of 80 across 281 interventional studies indexed under Spinal Stenosis.
Browse Spinal Stenosis studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
Compared within Spinal Stenosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Spinal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Definity Perflutren Lipid Microsphere Ultrasound Contrast
1. 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. 2. 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. 3. Prior to completion and closure of the incision, the study team will once more inject the ultrasound contrast to visualize the spinal cord. 4. 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.
Mean Change in Spinal Cord Contrast-Enhanced Ultrasound Signal Intensity Before and After Surgical Decompression
Contrast-enhanced ultrasound (CEUS) images were obtained intraoperatively before and after spinal cord decompression. Signal intensity (echogenicity) within the spinal cord at the decompressed segment was quantified from CEUS images and measured in dB/MHz/cm. The outcome measure was the change in signal intensity from pre-decompression imaging to post-decompression imaging. A positive value indicates increased perfusion signal following decompression, while a negative value indicates decreased perfusion signal.
Time frame: Intra-operative (approximately 3 hours)
| Milestone | Contrast Enhanced Ultrasound Arm |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Contrast-enhanced ultrasound (CEUS) images were obtained intraoperatively before and after spinal cord decompression. Signal intensity (echogenicity) within the spinal cord at the decompressed segment was quantified from CEUS images and measured in dB/MHz/cm. The outcome measure was the change in signal intensity from pre-decompression imaging to post-decompression imaging. A positive value indicates increased perfusion signal following decompression, while a negative value indicates decreased perfusion signal.
| dB/MHz/cm | Contrast Enhanced Ultrasound Arm |
|---|---|
| Mean Change in Spinal Cord Contrast-Enhanced Ultrasound Signal Intensity Before and After Surgical Decompression | 1.3 ± 5.4 |
Collected over From enrollement until end of follow up, up to 1 year.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Contrast Enhanced Ultrasound Arm | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | Contrast Enhanced Ultrasound Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 5 |
| Age, Continuous(Years) | Contrast Enhanced Ultrasound Arm |
|---|---|
| Mean | 68.4 ± 8.4 |
| Sex: Female, Male(Participants) | Contrast Enhanced Ultrasound Arm |
|---|---|
| Female | 10 |
| Male | 10 |
| Race (NIH/OMB)(Participants) | Contrast Enhanced Ultrasound Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 15 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Contrast Enhanced Ultrasound Arm |
|---|---|
| United States | 20 |
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Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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