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Evaluation of a Carbon Nanotube Enabled Solid-State Head CT

Primary Purpose

Head Trauma

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stationary Head CT (s-HCT)

About this trial

This is an interventional diagnostic trial for Head Trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

UNC HospitalsRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Head Trauma or Brain Bleed

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

Full Information

NCT ID

NCT04495634

First Posted

July 28, 2020

Last Updated

November 2, 2022

Sponsor

University of North Carolina, Chapel Hill

Collaborators

United States Department of Defense

1. Study Identification

Unique Protocol Identification Number

NCT04495634

Brief Title

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

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 12, 2022 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of North Carolina, Chapel Hill

Collaborators

United States Department of Defense

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head Trauma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Head Trauma or Brain Bleed

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Stationary Head CT (s-HCT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Sensitivity of Stationary Head CT for the Detection of a Hemorrhage

Description

Time Frame

Upon completion of all study image data collection for all participants [approximately 1 year]

Secondary Outcome Measure Information:

Title

Specificity of Stationary Head CT for the Detection of a Hemorrhage

Description

Time Frame

Upon completion of all study image data collection for all participants [approximately 1 year]

Title

Sensitivity of Stationary Head CT for the Detection of a Fracture

Description

Time Frame

Upon completion of all study image data collection for all participants [approximately 1 year]

Title

Specificity of Stationary Head CT for the Detection of a Fracture

Description

Time Frame

Upon completion of all study image data collection for all participants [approximately 1 year]

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Markeela Lipscomb, BS, CCRC

Phone

919-843-3670

markeela_lipscomb@med.unc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Doreen Steed, RT(R)(M)

Phone

919-966-0188

doreen_steed@med.unc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deanna Sasaki-Adams, MD

Organizational Affiliation

University of North Carolina, Chapel Hill

Official's Role

Principal Investigator

Facility Information:

Facility Name

UNC Hospitals

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Markeela Lipscomb, BS, CCRC

Phone

919-843-3670

markeela_lipscomb@med.unc.edu

First Name & Middle Initial & Last Name & Degree

Doreen Steed, RT(R)(M)

Phone

919-966-0188

doreen_steed@med.unc.edu

First Name & Middle Initial & Last Name & Degree

Yueh Lee, MD

First Name & Middle Initial & Last Name & Degree

Thad Benefield, MS

First Name & Middle Initial & Last Name & Degree

Deanna Sasaki-Adams, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Learn more about this trial

Evaluation of a Carbon Nanotube Enabled Solid-State Head CT

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