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| ID | Type | Description | Link |
|---|---|---|---|
| W81XWH1820043 | Other Grant/Funding Number | United States Department of Defense |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
This investigation will be a single arm, prospective clinical trial evaluating stationary head CT (s-HCT) as a diagnostic tool in patients with known head trauma. The investigators hypothesize that a stationary head CT (s-HCT) system based on the carbon nanotube linear array x-ray source can provide diagnostic quality head CT images. Patients included in the study 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Head Trauma or Brain Bleed | Experimental | Medically stable patients who have undergone conventional head CT imaging undergo imaging within 24 hours using the s-HCT system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stationary Head CT (s-HCT) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Stationary Head CT for the Detection of a Hemorrhage | 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. All stationary head CT scans will be reviewed in a standardized reader study at the conclusion of all study imaging. | Upon completion of all study image data collection for all participants [each participant was assessed approximately 1 hour for the duration of the single one-hour visit] |
| Specificity of Stationary Head CT for the Detection of a Hemorrhage | 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. All stationary head CT scans will be reviewed in a standardized reader study at the conclusion of all study imaging. | Upon completion of all study image data collection for all participants [each participant was assessed approximately 1 hour for the duration of the single one-hour visit] |
| Sensitivity of Stationary Head CT for the Detection of a Fracture | 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. All stationary head CT scans will be reviewed in a standardized reader study at the conclusion of all study imaging. | Upon completion of all study image data collection for all participants [each participant was assessed approximately 1 hour for the duration of the single one-hour visit] |
| Specificity of Stationary Head CT for the Detection of a Fracture | 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. All stationary head CT scans will be reviewed in a standardized reader study at the conclusion of all study imaging. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos Zamora, MD, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Hospitals | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41873211 | Derived | Gupta R, Kumar R, Kumar N, Singh P. Reimagining Brain Drug Delivery: Mechanistic and Translational Advances in Carbon Nanotube Nanomedicine. J Appl Toxicol. 2026 Jul;46(7):2250-2274. doi: 10.1002/jat.70154. Epub 2026 Mar 24. |
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Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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9 to 36 months following publication
The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Stationary Head CT (s-HCT): 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Stationary Head CT (s-HCT): 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sensitivity of Stationary Head CT for the Detection of a Hemorrhage | 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. All stationary head CT scans will be reviewed in a standardized reader study at the conclusion of all study imaging. | Posted | Mean | Standard Deviation | percent accurately predicted | Upon completion of all study image data collection for all participants [each participant was assessed approximately 1 hour for the duration of the single one-hour visit] | CT Scans | CT Scans |
|
Each participant assessed for AE's from the time of signing informed consent through the end of the single one-hour visit.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Stationary Head CT (s-HCT): 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doreen Steed, R.T. (R)(M) | University of North Carolina at Chapel Hill | 919-966-0188 | doreen_steed@med.unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2023 | Jun 25, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 25, 2023 | Aug 7, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006259 | Craniocerebral Trauma |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
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| Upon completion of all study image data collection for all participants [each participant was assessed approximately 1 hour for the duration of the single one-hour visit] |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Specificity of Stationary Head CT for the Detection of a Hemorrhage | 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. All stationary head CT scans will be reviewed in a standardized reader study at the conclusion of all study imaging. | Posted | Mean | Standard Deviation | percent accurately identified | Upon completion of all study image data collection for all participants [each participant was assessed approximately 1 hour for the duration of the single one-hour visit] | CT Scans | CT Scans |
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| Primary | Sensitivity of Stationary Head CT for the Detection of a Fracture | 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. All stationary head CT scans will be reviewed in a standardized reader study at the conclusion of all study imaging. | Posted | Mean | Standard Deviation | percent accurately predicted | Upon completion of all study image data collection for all participants [each participant was assessed approximately 1 hour for the duration of the single one-hour visit] | CT Scans | CT Scans |
|
|
|
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| Primary | Specificity of Stationary Head CT for the Detection of a Fracture | 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. All stationary head CT scans will be reviewed in a standardized reader study at the conclusion of all study imaging. | Posted | Mean | Standard Deviation | percent accurately identified | Upon completion of all study image data collection for all participants [each participant was assessed approximately 1 hour for the duration of the single one-hour visit] | CT Scans | CT Scans |
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| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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