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

• Status: Completed
• Conditions: Head Trauma
• Intervention / Treatment: Device: Stationary Head CT (s-HCT)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • UNC Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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)

Number of Arms

1

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.

Device: 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.

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	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.	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]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Upon completion of all study image data collection for all participants [approximately 1 year]
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.	Upon completion of all study image data collection for all participants [approximately 1 year]
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.	Upon completion of all study image data collection for all participants [approximately 1 year]

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Carlos Zamora, MD, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2022
• Primary Completion (Actual): September 13, 2023
• Study Completion (Actual): September 13, 2023

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: July 28, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: September 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Craniocerebral Trauma
• 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)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing Access Criteria: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No