- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04495634
Evaluation of a Carbon Nanotube Enabled Solid-State Head CT
Purpose: The purpose of this study is to evaluate stationary head CT (s-HCT) as a diagnostic tool in patients with known head trauma.
Participants: Participants will be 50 people who have had either a head trauma or a brain bleed and have undergone a head CT in the past 24 hours or who will undergo a CT scan of the head.
Procedures (methods): This investigation will be a single arm, prospective clinical trial. Participants will have one single visit, which will include the s-HCT scan. No follow-up is required. All images will be de-identified before inclusion within a reader study. The investigators will perform a reader study with physician readers comparing the acquired imaging s-HCT images and conventional head CT.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Doreen Steed, RT(R)(M)
- Phone Number: 919-966-0188
- Email: doreen_steed@med.unc.edu
Study Contact Backup
- Name: Markeela Lipscomb, BS, CCRC
- Phone Number: 919-843-3670
- Email: markeela_lipscomb@med.unc.edu
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- UNC Hospitals
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18 years of age or older
- Medically stable patient with head trauma or known intracranial hemorrhage (subdural or intraparenchymal) or skull fractures
- Patient has undergone conventional head CT imaging at UNC hospitals within the past 24 hours or will undergo a CT scan of the head
- Willing and able to provide written informed consent
Exclusion Criteria:
- Unable to provide consent
- Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 24 hours prior to the research scan, or on the basis of patient history, e.g., tubal ligation, hysterectomy or a minimum of 1 year without menses)
- Breastfeeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Head Trauma or Brain Bleed
Medically stable patients who have undergone conventional head CT imaging undergo imaging within 24 hours using the s-HCT system.
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The system consists of a total of three x-ray sources and nine x-ray detectors with an estimation of approximately 150 projection angles per slice, with less than a minute per slice reconstruction.
Radiation dose will be configured as to not exceed that of a conventional head CT, or 2 mSv.
The subjects will be positioned on a medical procedure table that will move the subject through the scanning system at the rate of roughly 1 cm per second, during which the necessary x-ray projections will be acquired.
The head will be positioned in a carbon fiber head holder from a clinical CT scanner that is secured to the table.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity of Stationary Head CT for the Detection of a Hemorrhage
Time Frame: Upon completion of all study image data collection for all participants [approximately 1 year]
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Sensitivity of stationary head CT for the detection of a hemorrhage using a reader study is defined as the ability of readers (radiologists) to use the stationary head CT to predict hemorrhage using conventional head CT as the gold standard.
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Upon completion of all study image data collection for all participants [approximately 1 year]
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specificity of Stationary Head CT for the Detection of a Hemorrhage
Time Frame: Upon completion of all study image data collection for all participants [approximately 1 year]
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Specificity of stationary head CT for the detection of a hemorrhage using a reader study is defined as the ability of readers (radiologists) to use the stationary head CT to distinguish between individuals that do not have a hemorrhage using conventional head CT as the gold standard.
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Upon completion of all study image data collection for all participants [approximately 1 year]
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Sensitivity of Stationary Head CT for the Detection of a Fracture
Time Frame: Upon completion of all study image data collection for all participants [approximately 1 year]
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Sensitivity of stationary head CT for the detection of a fracture using a reader study is defined as the ability of readers (radiologists) to use the stationary head CT to predict a fracture using conventional head CT as the gold standard.
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Upon completion of all study image data collection for all participants [approximately 1 year]
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Specificity of Stationary Head CT for the Detection of a Fracture
Time Frame: Upon completion of all study image data collection for all participants [approximately 1 year]
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Specificity of stationary head CT for the detection of a fracture using a reader study is defined as the ability of readers (radiologists) to use the stationary head CT to distinguish between individuals that do not have a fracture using conventional head CT as the gold standard.
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Upon completion of all study image data collection for all participants [approximately 1 year]
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Deanna Sasaki-Adams, MD, University of North Carolina, Chapel Hill
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-0614
- W81XWH1820043 (Other Grant/Funding Number: United States Department of Defense)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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