Evaluation of a Carbon Nanotube Enabled Solid-State Head CT

University of North Carolina (UNC)

Status: Completed

Conditions: Head Trauma

Treatments: Device: Stationary Head CT (s-HCT)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04495634

20-0614

W81XWH1820043 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Head Trauma or Brain Bleed

Experimental group

Description:

Medically stable patients who have undergone conventional head CT imaging undergo imaging within 24 hours using the s-HCT system.

Treatment:

Device: Stationary Head CT (s-HCT)