Trial Outcomes & Findings for Evaluation of a Carbon Nanotube Enabled Solid-State Head CT (NCT NCT04495634)

Last Updated: 2024-10-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

17 participants

Primary outcome 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]

Results posted on

2024-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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.
Overall Study STARTED	17
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of a Carbon Nanotube Enabled Solid-State Head CT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Head Trauma or Brain Bleed n=17 Participants Medically stable patients who have undergone conventional head CT imaging undergo imaging within 24 hours using the s-HCT system. 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	17 Participants n=5 Participants

PRIMARY outcome

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]

Outcome measures

Outcome measures
Measure	Head Trauma or Brain Bleed n=17 CT Scans Medically stable patients who have undergone conventional head CT imaging undergo imaging within 24 hours using the s-HCT system. 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.
Sensitivity of Stationary Head CT for the Detection of a Hemorrhage	33 percent accurately predicted Standard Deviation 29

PRIMARY outcome

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]

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.

Outcome measures

Outcome measures
Measure	Head Trauma or Brain Bleed n=17 CT Scans Medically stable patients who have undergone conventional head CT imaging undergo imaging within 24 hours using the s-HCT system. 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.
Specificity of Stationary Head CT for the Detection of a Hemorrhage	98 percent accurately identified Standard Deviation 4

PRIMARY outcome

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]

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.

Outcome measures

Outcome measures
Measure	Head Trauma or Brain Bleed n=17 CT Scans Medically stable patients who have undergone conventional head CT imaging undergo imaging within 24 hours using the s-HCT system. 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.
Sensitivity of Stationary Head CT for the Detection of a Fracture	32 percent accurately predicted Standard Deviation 16

PRIMARY outcome

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]

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.

Outcome measures

Outcome measures
Measure	Head Trauma or Brain Bleed n=17 CT Scans Medically stable patients who have undergone conventional head CT imaging undergo imaging within 24 hours using the s-HCT system. 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.
Specificity of Stationary Head CT for the Detection of a Fracture	16 percent accurately identified Standard Deviation 10

Adverse Events

Head Trauma or Brain Bleed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Doreen Steed, R.T. (R)(M)

University of North Carolina at Chapel Hill

Phone: 919-966-0188

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place