Spine DiseaseNCT05530798

CEUS For Intraoperative Spinal Cord Injury

A study testing Definity Perflutren Lipid Microsphere Ultrasound Contrast in people with Spine Disease and Spinal Stenosis, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Spine Disease, Spinal Stenosis, Spinal Injury
What is being tested?: Definity Perflutren Lipid Microsphere Ultrasound Contrast
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2023to 1 Aug 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients consented and scheduled for posterior cervicothoracic decompression surgery with the PI for the diagnosis of cervicothoracic myeloradiculopathy
Age 18-80

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: 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.

Conditions: Spine Disease, Spinal Stenosis, Spinal Injury, Spinal Cord Diseases, Spinal Cord Injuries, Spinal Cord Compression
Being tested: Definity Perflutren Lipid Microsphere Ultrasound Contrast
Keywords: Contrast Enhanced Ultrasound, CEUS
Medical subject headings: Spinal Diseases, Spinal Stenosis, Spinal Injuries, Spinal Cord Diseases, Spinal Cord Injuries, Spinal Cord Compression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Definity Perflutren Lipid Microsphere Ultrasound ContrastDevice
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.

Study groups in NCT05530798
Study group	Role	What they receive
Contrast Enhanced Ultrasound Arm	Experimental	Not described Receives: Device: Definity Perflutren Lipid Microsphere Ultrasound Contrast

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Intra-operative (approximately 3 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20231 Aug 2025

First posted7 Sep 2022
Study start1 Dec 2023
Primary completion1 Aug 2025
Study completion1 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Spine DiseaseStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05530798
Sponsor's protocol ID: 00120959
Status last verified: Sep 2026
First submitted: 30 Aug 2022
Last updated: 15 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Not yet recruiting
A Comparison of the Effects of Exercise Methods for Adolescent Hyperkyphosis on the Sensorimotor System
Kyphosis Postural Thoracic, Kyphosis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis

All Spine Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Contrast Enhanced Ultrasound for The Evaluation of Intraoperative Spinal Cord Injury Following Surgical Decompression of a Chronically Compressed Spinal Cord
ClinicalTrials.gov ID: NCT05530798
Acronym / sponsor ID: 00120959
Conditions: Spine Disease, Spinal Stenosis, Spinal Injury, Spinal Cord Diseases, Spinal Cord Injuries, Spinal Cord Compression
Keywords: Contrast Enhanced Ultrasound, CEUS
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: South Carolina Spinal Cord Injury Research Fund
Study start: 1 Dec 2023 (actual)
Primary completion: 1 Aug 2025 (actual)
Study completion: 1 Aug 2025 (actual)
First posted: 7 Sep 2022 (actual)
Results: Posted 4 Sep 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Contrast Enhanced Ultrasound Arm	Experimental	Device: Definity Perflutren Lipid Microsphere Ultrasound Contrast

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients consented and scheduled for posterior cervicothoracic decompression surgery with the PI for the diagnosis of cervicothoracic myeloradiculopathy
Age 18-80

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Definity Perflutren Lipid Microsphere Ultrasound Contrast1. 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.	Device	Contrast Enhanced Ultrasound Arm

Primary outcome

Mean Change in Spinal Cord Contrast-Enhanced Ultrasound Signal Intensity Before and After Surgical Decompression
Time frame: Intra-operative (approximately 3 hours)
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.

Results and safety

Results posted to the registry on 4 Sep 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Contrast Enhanced Ultrasound Arm	20	20

Primary outcome: Mean Change in Spinal Cord Contrast-Enhanced Ultrasound Signal Intensity Before and After Surgical Decompression

Time frame: Intra-operative (approximately 3 hours). Mean (Standard Deviation). Unit: dB/MHz/cm

Measure	Contrast Enhanced Ultrasound Arm n = 20
Value	1.3 (5.4)

Adverse events

Time frame: From enrollement until end of follow up, up to 1 year.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Contrast Enhanced Ultrasound Arm	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Limitations and caveats (from the sponsor): This study has several limitations. Primarily, the small sample size limits generalizability and introduces potential sampling error. In addition, surgeries and imaging were performed by 2 surgeons, introducing variability in surgical and sonographic technique. Future work should involve multicenter, prospective trials using standardized protocols, with long-term clinical follow-up to build a large dataset allowing for a more robust assessment of the correlation of CEUS spinal cord perfusion ind

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Spine Disease

Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Recruiting
Efficacy of a Self-Management Smartphone App to Improve Safety Skills in Patients With Inflammatory Arthritis
Rhumatoid Arthisis, Spondyloarthritis (SA)
Not yet recruiting
A Comparison of the Effects of Exercise Methods for Adolescent Hyperkyphosis on the Sensorimotor System
Kyphosis Postural Thoracic, Kyphosis
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Brian F Saway, MD principal investigator

Medical University of South Carolina

Stephen Kalhorn, MD principal investigator

Medical University of South Carolina

Jessica Barley, PhD principal investigator

Medical University of South Carolina

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Definity Perflutren Lipid Microsphere Ultrasound Contrast in people with Spine Disease and Spinal Stenosis, run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Spinal Cord Contrast-Enhanced Ultrasound Signal Intensity Before and After Surgical Decompression (time frame: Intra-operative (approximately 3 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05530798.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.