Contrast-Enhanced Ultrasound for Spinal Cord Injury

Overseen By Amy Anderson

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Washington

Disqualifiers: Head injury, Cardiopulmonary conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with recent spinal cord injuries using a special imaging technique. It aims to determine if the contrast agent Perflutren lipid (also known as Definity or Luminity) can more effectively reveal blood flow issues in the spine, potentially aiding doctors in improving treatment and outcomes. The trial seeks participants who have sustained a spinal cord injury within the last 24 hours and are stable enough for specific medical procedures. As a Phase 4 trial, this research focuses on understanding how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for Perflutren lipid?

Research has shown that Perflutren lipid, used in special ultrasound scans, is very safe. Studies have found it safe for individuals with heart and lung issues, and most people do not experience serious side effects.

Serious allergic reactions, such as anaphylaxis, to Perflutren lipid are extremely rare. Only one case has been reported, linked to an ingredient in the product. Additionally, no major safety differences exist between older and younger patients using this treatment.

The FDA has already approved this treatment for other uses, supporting its safety. In this trial, the researchers are exploring its use for spinal cord injuries, and existing data appears promising for safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the use of contrast-enhanced ultrasound with Perflutren lipid for spinal cord injuries because it offers a new way to visualize the spinal cord in real-time. Unlike traditional imaging methods like MRI or CT scans, which can be time-consuming and less dynamic, this technique provides continuous imaging, allowing doctors to monitor changes as they happen. The use of Perflutren lipid as a contrast agent enhances the visibility of blood flow and tissue structure, potentially leading to faster and more precise assessments of spinal cord injuries. This could improve decision-making and treatment planning, offering hope for better outcomes in these challenging cases.

What evidence suggests that contrast-enhanced ultrasound is effective for traumatic spinal cord injury?

Research has shown that contrast-enhanced ultrasound (CEUS) effectively detects blood flow changes in spinal cord injuries. This is crucial because reduced blood flow can worsen the injury. Animal studies have demonstrated that CEUS can identify these changes in injured spinal cords. In this trial, participants will receive a bolus IV injection of a contrast agent called perflutren lipid, which makes these changes visible during ultrasound scans. This could enable doctors to better understand and potentially improve treatment for spinal cord injuries. ^{1 3 6 7 8}

Who Is on the Research Team?

Christoph Hofstetter, MD, PhD

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for patients with traumatic spinal cord injury. It's aimed at those who have recently suffered from this condition and are experiencing swelling and pressure in the spinal area, which affects blood flow.

Inclusion Criteria

I have had a spinal cord injury within the last 24 hours.

My spinal cord injury ranges from mild to complete loss of function below the injury.

I am medically fit for spine surgery.

Exclusion Criteria

My spinal cord injury is below the middle of my back.

Known sensitivity to lipid microsphere or its components, such as polyethylene glycol (PEG)

History of anaphylactoid reactions from ultrasound enhancing agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Surgery and Intraoperative Assessment

Routine surgery for decompression and stabilization of the spine, followed by contrast-enhanced ultrasound (CEUS) to assess blood flow at the site of injury

Immediate (during surgery)

1 visit (in-person, surgical)

Post-operative Follow-up

Participants receive routine MRI imaging within one week and one year post-surgery to monitor recovery and outcomes

1 year

2 visits (in-person)

Long-term Follow-up

Monitoring of chronic neurological outcomes and validation of CEUS biomarkers over a two-year period

2 years

What Are the Treatments Tested in This Trial?

Interventions

• Perflutren lipid

Trial Overview The study is testing Perflutren lipid, a contrast agent used in ultrasound imaging to visualize blood flow in the spinal cord after an acute injury. The goal is to optimize treatment by monitoring blood flow changes.

How Is the Trial Designed?

Group I: Contrast-enhanced ultrasound in traumatic spinal cord injury Experimental Treatment 1 Intervention

A bolus IV injection of Perflutren lipid contrast agent will be given. Continuous imaging will be obtained.

Perflutren lipid is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Definity for:

• Cardiovascular imaging
• Liver imaging

Approved in European Union as Luminity for:

• Cardiovascular imaging
• Liver imaging

Approved in Canada as Definity for:

• Cardiovascular imaging
• Liver imaging

Who Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

Dynamic contrast-enhanced MR perfusion imaging of intradural spinal lesions is feasible at both 1.5T and 3T MRI machines, with a study involving 15 patients.

The 3T MRI provided significantly better signal-to-noise ratio and contrast-to-noise ratio compared to the 1.5T, indicating improved image quality for better diagnosis and assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic Contrast-Enhanced MR Perfusion of Intradural Spinal Lesions. Cuvinciuc, V., Viallon, M., Barnaure, I., et al.[2021]

This study utilized contrast-enhanced ultrasound (CEUS) to effectively measure spinal cord perfusion in rhesus monkeys with acute spinal cord injuries, revealing hypoperfusion at the injury epicenter and hyperperfusion in adjacent areas.

Quantitative analysis showed significant changes in perfusion parameters, with peak intensity decreasing at the injury site and increasing in surrounding regions, indicating that CEUS could be a valuable tool for real-time monitoring of spinal cord injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative contrast-enhanced ultrasonography for microcirculatory evaluation in rhesus monkey with spinal cord injury. Huang, L., Chen, K., Chen, FC., et al.[2018]

Using contrast-enhanced ultrasound (CEUS) at higher frequencies (15 MHz) allows for improved imaging of blood flow changes in the spinal cord after injury, revealing significant differences in perfusion deficits between moderate and severe injuries in a rodent model.

The study found that acute blood flow changes, such as delayed microbubble arrival times and morphological alterations in blood vessels, correlate with chronic outcomes in locomotive function and the amount of spared spinal cord tissue, highlighting the potential of CEUS in assessing spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Changes Associated with Spinal Cord Injury Assessed by Non-linear Doppler Contrast-Enhanced Ultrasound. Bruce, M., DeWees, D., Harmon, JN., et al.[2023]

Real-time contrast enhanced ultrasound imaging (CEU) effectively assesses spinal cord blood flow (SCBF) changes in a rat model of spinal cord injury (SCI), providing a new method to evaluate neuroprotective therapies.

The study found critical ischemia at the injury epicenter 15 minutes post-SCI, while adjacent areas showed significantly reduced SCBF, highlighting the importance of targeting the ischemic penumbra zone for potential treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast enhanced ultrasound imaging for assessment of spinal cord blood flow in experimental spinal cord injury. Dubory, A., Laemmel, E., Badner, A., et al.[2018]

Contrast-enhanced ultrasound (CEUS) effectively quantifies spinal cord perfusion changes in a porcine model of acute spinal cord injury, revealing hypoperfusion at the injury site and hyperperfusion in adjacent areas.

The study demonstrated significant alterations in blood flow patterns post-injury, with CEUS providing valuable insights into microcirculatory changes that correlate with neurological function deterioration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative assessment of spinal cord perfusion by using contrast-enhanced ultrasound in a porcine model with acute spinal cord contusion. Huang, L., Lin, X., Tang, Y., et al.[2016]

Ultrafast contrast-enhanced ultrasound (CEUS) imaging effectively visualizes and quantifies acute blood flow changes in a rat model of traumatic spinal cord injury, revealing significant loss of perfusion and structural alterations in the spinal vasculature immediately after injury.

CEUS demonstrated the ability to assess local tissue perfusion and blood flow velocities, suggesting its potential clinical application for determining the extent and severity of spinal cord injuries in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contrast-Enhanced Ultrasound for Assessment of Local Hemodynamic Changes Following a Rodent Contusion Spinal Cord Injury. Khaing, ZZ., Cates, LN., Hyde, J., et al.[2020]

A modified fluorometric method using FITC-conjugated dextran effectively measures vascular permeability changes in rat spinal cord injury, demonstrating a reliable way to evaluate drug effects on this condition.

The study found that vascular injury, indicated by the vascular injury index (VII), increased with the severity of trauma, peaking at 2 hours post-injury, highlighting the method's sensitivity to changes in vascular permeability following spinal cord trauma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sensitive fluorometric method for measurement of vascular permeability in spinal cord injury. Qu, ZX., Xu, J., Perot, PL., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06654804

Contrast-enhanced Ultrasound in the Treatment of Acute ... The investigators plan to use contrast-enhanced ultrasound (CEUS) to determine a decrease in the blood flow in the spinal cord at the site of injury, during the ...

2. withpower.com withpower.com/trial/contrast-enhanced-ultrasound-for-spinal-cord-injury-cf86a

Contrast-Enhanced Ultrasound for Spinal Cord Injury The research shows that contrast-enhanced ultrasound (CEUS) can effectively assess blood flow changes in spinal cord injuries, which is crucial for ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11045808/

Contrast enhanced ultrasound for traumatic spinal cord injury Studies in animal models have shown CEUS to be an effective non-invasive imaging modality that can detect perfusion changes of injured spinal cords in real ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06654804/contrast-enhanced-ultrasound-in-the-treatment-of-acute-spinal-cord-injury

Contrast-enhanced Ultrasound in the Treatment of Acute ... The investigators plan to use contrast-enhanced ultrasound (CEUS) to determine a decrease in the blood flow in the spinal cord at the site of injury.

5. definityimaging.com definityimaging.com/

DEFINITY® (Perflutren Lipid Microsphere) Diagnostic ... Efficacy and safety of the novel ultrasound contrast agent perflutren (definity) in patients with suboptimal baseline left ventricular echocardiographic images.

6. definityimaging.com definityimaging.com/safety

Safety Profile of DEFINITY® for Medical Imaging DEFINITY® is demonstrated to be safe in patients with a high prevalence of cardiopulmonary disease and pulmonary hypertension.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12060560/

Perflutren lipid microspheres for echocardiogram contrast Anaphylaxis to perflutren lipid microsphere is very rare, with only one case report clearly attributing the reaction to the PEG excipient.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/021064s025s029lbl.pdf

Definity - accessdata.fda.gov No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not ...