Trial Outcomes & Findings for tSCI Contrast Enhanced Ultrasound Study (NCT NCT04056988)
NCT ID: NCT04056988
Last Updated: 2026-04-29
Results Overview
Feasibility was defined as successful intravenous administration of perflutren lipid microsphere contrast agent and acquisition of interpretable intraoperative contrast-enhanced ultrasound (CEUS) perfusion imaging during spinal decompressive surgery in patients with acute traumatic spinal cord injury.
COMPLETED
PHASE4
27 participants
Operative period to one-week or hospital discharge (first occurring event)
2026-04-29
Participant Flow
Recruitment occurred when patients were admitted for the treatment of an acute spinal injury and were screened for eligibility. The approved number of subjects did not match the number of eligible, recruited subjects.
The study was approved for a total of 80 patients during the approval/funding period. 27 subjects were recruited to the study, with a total of 22 completing the study. 5 subjects succumbed to their injuries, not related to the study. Subjects were enrolled in the study when the inclusion criteria were met and consent was obtained. Actual enrollment did not meet the approved, anticipated enrollment number during the study.
Participant milestones
| Measure |
Acute Spinal Cord Injury Patients to Undergo Contrast-enhanced Imaging During Surgery.
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.
Perflutren Lipid Microsphere: Perflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
Acute Spinal Cord Injury Patients to Undergo Contrast-enhanced Imaging During Surgery.
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.
Perflutren Lipid Microsphere: Perflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound.
|
|---|---|
|
Overall Study
Death
|
5
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Acute Spinal Cord Injury Patients to Undergo Contrast-enhanced
n=27 Participants
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.
Perflutren Lipid Microsphere: Perflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
55 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Operative period to one-week or hospital discharge (first occurring event)Feasibility was defined as successful intravenous administration of perflutren lipid microsphere contrast agent and acquisition of interpretable intraoperative contrast-enhanced ultrasound (CEUS) perfusion imaging during spinal decompressive surgery in patients with acute traumatic spinal cord injury.
Outcome measures
| Measure |
Acute Spinal Cord Injury Patients to Undergo Contrast-enhanced Imaging During Surgery.
n=27 Participants
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.
Perflutren Lipid Microsphere: Perflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound.
|
|---|---|
|
Feasibility of Intraoperative Contrast-enhanced Ultrasound in Acute Traumatic Spinal Cord Injury - Number of Participants With Successful Intraoperative Contrast-enhanced Ultrasound in Acute Traumatic Spinal Cord Injury
|
27 Participants
|
Adverse Events
Acute Spinal Cord Injury Patients to Undergo Contrast-enhanced
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place