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Contrast Enhanced Ultrasound for Spinal Cord Injury

Phase 4

Waitlist Available

Led By Christoph P Hofstetter, MD

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Acute <72 hours spinal cord injury

Medically stable to undergo routine decompression and spinal realignment

Must not have

Not clinically stable for spinal surgery

<18 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intra-operative

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

Drug Has Already Been Approved

Pivotal Trial

No Placebo-Only Group

Summary

This trial will use ultrasound to look for decreased blood flow in the spinal cord at the site of injury in order to improve treatment for patients with tSCI.

Who is the study for?

This trial is for men and women with a recent spinal cord injury (less than 72 hours old) who are medically stable enough to undergo routine spine surgery. They should have an ASIA grade of A to D, indicating varying levels of impairment. People under 18 or those not stable for surgery, as well as individuals with traumatic brain injuries, cannot participate.

What is being tested?

The study tests the use of contrast-enhanced ultrasound (CEUS) during routine spine surgery in patients with acute spinal cord injury. CEUS will be used to detect reduced blood flow at the injury site which could inform treatment decisions and potentially improve outcomes.

What are the potential side effects?

While specific side effects are not listed here, contrast agents like Perflutren Lipid Microsphere can sometimes cause allergic reactions, discomfort at the injection site, or changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a spinal cord injury in the last 72 hours.

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I am medically fit for spine surgery.

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My spinal injury is classified between ASIA A to D.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not a candidate for spinal surgery due to my condition.

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I am under 18 years old.

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I have had a traumatic brain injury.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intra-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~intra-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and intra-operative for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Use of CEUS to improve post operative outcomes in acute spinal cord injury

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Acute spinal cord injury patients to undergo contrast-enhancedExperimental Treatment1 Intervention

Perflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound. A hand-held intraoperative ultrasound probe will be used to collect sagittal images of the spinal cord centered above the spinal cord injury. A bolus IV injection of DEFINITY® contrast agent (1.5ml DEFINITY®/8.5ml saline) will be given. Continuous imaging will be obtained to record contrast inflow and washout.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Perflutren

FDA approved

0 / 6Eligibility criteria met