Clinical trial NCT04495634: Evaluation of a Carbon Nanotube Enabled Solid-State Head CT
Official title: Evaluation of a Carbon Nanotube Enabled Solid-State Head CT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head Trauma
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2020-08-03
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity of Stationary Head CT for the Detection of a Hemorrhage
timeFrame: 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]
measure: Specificity of Stationary Head CT for the Detection of a Hemorrhage
timeFrame: 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]
measure: Sensitivity of Stationary Head CT for the Detection of a Fracture
timeFrame: 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]
measure: Specificity of Stationary Head CT for the Detection of a Fracture
timeFrame: 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 outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Carlos Zamora, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: