Evaluation of a Carbon Nanotube Enabled Solid-State Head CT

Not Applicable

Completed

• Conditions: Head Trauma
• Interventions: Device: Stationary Head CT (s-HCT)

• Registration Number: NCT04495634
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

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 Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-28
• Study First Posted: 2020-08-03
• Study Start: 2022-10-12
• Primary Completion: 2023-09-13
• Study Completion: 2023-09-13
• Status Verified: 2024-08
• Results First Submitted: 2024-08-09
• Results First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Results First Posted: 2024-10-08
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Head Trauma or Brain Bleed	Stationary Head CT (s-HCT)	Medically stable patients who have undergone conventional head CT imaging undergo imaging within 24 hours using the s-HCT system.

Primary Outcome Measures

Name	Time	Method
Sensitivity of Stationary Head CT for the Detection of a Hemorrhage	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 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.
Specificity of Stationary Head CT for the Detection of a Hemorrhage	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 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.
Sensitivity of Stationary Head CT for the Detection of a Fracture	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 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.
Specificity of Stationary Head CT for the Detection of a Fracture	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 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.

Trial Locations

Locations (1)

UNC Hospitals; 🇺🇸 Chapel Hill, North Carolina, United States