Evaluation of a Carbon Nanotube Enabled Solid-State Head CT
Phase: NA
Conditions: Head Trauma
Sponsor: University of North Carolina, Chapel Hill

 
Evaluation of a Carbon Nanotube Enabled Solid-State Head CT 
 
 
 
 
NCT number NCT04495634 
Document Date 06/08/2023 
 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
 
 
PROTOCOL TITLE  
Evaluation of a Carbon Nanotube Enabled Solid-State Head CT 
 
Principal Investigator 
Brian David Sindelar, MD 
 
The University of North Carolina at Chapel Hill  
Campus Box 7060 
Chapel Hill, NC 27599-7060 
Phone: (919) 966-1374 
Email: bsind@email.unc.edu 
 
Co-Investigators 
Yueh Lee, MD, PhD 
 
Biostatistician  
Thad Benefield 
 
 
Sponsor:  University of North Carolina  
 
Funding Source: Department of Defense 
 
Date of Protocol: June 08, 2023 
 
 
 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
 
PROTOCOL TITLE  
Evaluation of a Carbon Nanotube Enabled Solid-State Head CT 
 
Principal Investigator 
Brian David Sindelar, MD 
The University of North Carolina at Chapel Hill  
Campus Box 7060 
Chapel Hill, NC 27599-7060 
Phone: (919) 966-1374 
Email: bsind@email.unc.edu 
 
 
 
 
 
Signature Page 
 
The signature below constitutes the approval of this protocol and the attachments, and 
provides the necessary assurances that this trial will be conducted according to all 
stipulations of the protocol, including all statements regarding confidentiality, and 
according to local legal and regulatory requirements and applicable U.S. federal regulations 
and ICH guidelines. 
 
Principal Investigator (PI) Name:_______________________ 
 
PI Signature: ___________________ 
 
Date:____________________ 
 
Date of Protocol: June 08, 2023 
 
 
 
 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
1 
TABLE OF CONTENTS 
ABBREVIATIONS AND DEFINITIONS .......................................................................3 
1.0 
BACKGROUND AND RATIONALE ..................................................................4 
1.1 
Study Synopsis ......................................................................................................4 
1.2 
Disease Background ..............................................................................................4 
1.3 
Investigational Imaging Modality .........................................................................4 
1.4 
Rationale................................................................................................................6 
2.0 
STUDY OBJECTIVES ...........................................................................................6 
2.1 
Primary Objectives ................................................................................................7 
2.2 
Secondary Objectives ............................................................................................7 
2.3 
Outcome Variables ................................................................................................7 
3.0 
PATIENT ELIGIBILITY ......................................................................................7 
3.1 
Inclusion Criteria ...................................................................................................7 
3.2 
Exclusion Criteria ..................................................................................................7 
4.0 
STUDY PLAN .........................................................................................................7 
4.1 
STUDY SCHEMA ................................................................................................8 
4.2 
Study Procedures ...................................................................................................8 
4.3 
Time and Events Table ..........................................................................................9 
5.0 
INVESTIGATIONAL DEVICE ..........................................................................10 
5.1 
Investigational Device Description .....................................................................10 
5.2 
Expected Risks ....................................................................................................10 
6.0 
UNANTICIPATED CONCERNS (DEVICES) ..................................................10 
6.1 
Unanticipated Adverse Device Effect (UADE) ..................................................11 

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Non-Oncology Imaging Protocol Template 
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6.2 
Unanticipated Problems (UP)..............................................................................11 
6.3 
Reporting .............................................................................................................11 
7.0 
STATISTICAL CONSIDERATIONS ................................................................12 
7.1 
Study Design .......................................................................................................12 
7.2 
Sample Size  Rationale ........................................................................................12 
7.3 
Data Analysis Plans .............................................................................................14 
8.0 
STUDY MANAGEMENT ....................................................................................15 
8.1 
Institutional Review Board (IRB) Approval and Consent ..................................15 
8.2 
Registration Procedures.......................................................................................16 
8.3 
Data Management ...............................................................................................16 
8.4 
Adherence to the Protocol ...................................................................................17 
8.5 
Amendments to the Protocol ...............................................................................18 
8.6 
Record Retention .................................................................................................18 
8.7 
Obligations of Investigators ................................................................................19 
9.0 
PLANS FOR PUBLICATION .............................................................................19 
10.0 REFERENCES ......................................................................................................19 
11.0 APPENDICES .......................................................................................................22 
 
 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
3 
ABBREVIATIONS AND DEFINITIONS 
 
 
 
 
Abbreviation  Definition  
ACR 
American College of Radiology 
ART 
Algebraic Reconstruction Technique 
CDE 
Common Data Elements 
CNT 
Carbon nanotube 
CT 
Computed Tomography 
FOB 
Forward Operating Base 
GPU 
Graphics Processing Unit 
MRI 
Magnetic Resonance Imaging 
MTF 
Modulation Transfer Function 
NPS 
Noise Power Spectrum 
PACS 
Picture Archiving and Communication System 
ROC 
Receiver Operator Curve 
s-HCT 
Stationary Head Computed Tomography 
TBI  
Traumatic Brain Injury 
TV-ART 
Total Variation minimization method with Algebraic 
Reconstruction Technique 
UQI  
Universal Quality Index 
XCAT 
Extended Cardiac-Torso 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
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1.0 
BACKGROUND AND RATIONALE 
1.1 
Study Synopsis 
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. We 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 5 days or 
who will undergo a CT scan of the head. 
1.2 
Disease Background  
The diagnosis of traumatic brain injury (TBI) has become of paramount 
importance in combat casualty care. In a resource poor environment, the lack of 
advanced cross-sectional imaging modalities such as computed tomography (CT) 
limits the ability of forward surgical teams to diagnose life threatening head 
injuries. As a result, the vast majority of patients with head trauma must be 
transported to facilities with CT or MRI capabilities to better assess the extent of 
head trauma. This approach leads to medically unnecessary transport of soldiers 
and potentially delays in appropriate care. Unfortunately, conventional imaging 
modalities such as ultrasound and conventional radiographs are essentially useless 
in diagnosing life-threatening conditions in the brain, including intraparenchymal 
hemorrhage, subdural or epidural hematomas. To achieve the appropriate level of 
care, advanced imaging modalities are necessary. Current computed tomography 
systems, unfortunately, are highly complex instruments requiring the rapid 
rotation of an x-ray tube and detector system. This approach does not lend itself to 
use except for in well controlled environments, such as within a hospital. 
1.3 
Investigational Imaging Modality  
Recently, we have developed the carbon nanotube (CNT) linear x-ray source 
array. This x-ray generation approach utilizes field emission which allows two 
primary advantages: precise x-ray pulse control and close physical placement of 
multiple x-ray sources. A solid state x-ray source array can provide the necessary 
x-ray projections to generate CT images without any mechanical motion of 
components. The goal of this study is to evaluate a solid-state no-rotation x-ray 
CT system for applications in head trauma imaging in the field.  
 
We have designed a solid-state head CT system to enable head CT scanning at 
Forward Operating Bases (FOBs) and potentially in patient transport vehicles 
(ambulance or helicopter). A number of mobile dedicated head CT scanners are 
commercially available.1 These devices, for the most part, have been used in 
intensive care unit or otolaryngology clinical applications. Some have been 
utilized in ambulance settings, requiring significant maintenance and ambulance 
modification to provide a stable imaging platform.2 The slip-ring technology that 
enables these and other modern CT systems allows the transmission of data and 
power to the rotating source and detector. The slip-ring interface, however, also 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
5 
requires high precision and regular maintenance to preserve transmission, making 
them unsuitable for FOBs.3 
 
A solid-state system could eliminate the mechanical limitations of placing a 
scanner at an FOB or within a vehicle, and bring the diagnostic device closer to 
the patient.  
 
The figures below represent the current prototype of the proposed Head CT 
system. Three, 45 (forty-five) beam x-ray sources individually are positioned 
opposite a set of three detectors that are positioned similar to Figure 1(b), with the 
position of the head represented by the ACR phantom (brown cylinder with small 
inserts). The x-ray tubes, Model IND1645, are manufactured by NuRay 
(http://www.nuraytech.com/en/) and were custom developed for this purpose.  
 
The detectors that will be used are the Xineos 2301 (Teledyne DALSA) 
(https://www.teledynedalsa.com/en/products/imaging/medical-x-ray-
detectors/xineos-scanning/, a 7 x 23 cm detector with high sensitivity in the 
relevant diagnostic x-ray energies. So, the system will consist of a total of three x-
ray sources and nine x-ray detectors. 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.  
 
We are estimating 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 workflow for the system 
will be similar to that of a conventional CT, such that the patient is positioned 
within the head holder on the scanner. Then, once scanning begins, the patient 
will be automatically advanced into the system across the scan range of the head, 
during which the necessary x-ray projections will be acquired.  
 
 

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Non-Oncology Imaging Protocol Template 
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February 2017 
 
6 
 
 
1.4 
Rationale 
The current Neurosurgery and Severe Head Injury guidelines in the Joint Trauma 
System (JTS) Clinical Practice Guide (CPG) dictate that all moderate to severe 
head injuries received a head CT. However, though neurosurgical support is 
available at Role 3 facilities, CT scanner capability is only available at Role 4. 
Thus, there is a significant discrepancy need for improved neuroimaging at Role 3 
facilities to prevent unnecessary transport to Role 4 facilities at high, unnecessary 
cost. Imaging TBI patients earlier could also offer more timely transport to the 
higher level of care necessary to prevent delay of care which may contribute to 
the patient condition deterioration. 
 
Per the JTS CPG guidelines, subjects with Glasgow Coma Scores from 9 to 12 are 
considered a moderate level of injury, with severe injury between 3 and 8. 
Unfortunately, it is also well known that the GCS does not fully capture the extent 
of TBI, especially in closed head injury. Recently, studies have also shown that 
identifying intracranial hemorrhage, is an essential component in providing the 
appropriate level of care and predicting patient outcomes. 
 
Computed tomography (CT) has become one of the most commonly used imaging 
modalities. The popularity of CT as a diagnostic imaging tool is understandable – 
no other modality offers 3-D imaging with the same rapidity and soft tissue 
discrimination as CT. An estimated 62 million CT scans were performed in 2010 
in the US. However, these devices remain complex and difficult to deploy in 
Forward Operating Bases where they are most needed as a diagnostic tool. 
 
2.0 
STUDY OBJECTIVES 

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2.1 
Primary Objectives 
To estimate sensitivity of stationary head CT for the detection of a hemorrhage 
using a reader study. 
2.2 
Secondary Objectives  
• To estimate specificity of stationary head CT for the detection of a 
hemorrhage using a reader study. 
• To estimate sensitivity of stationary head CT for the detection of a fracture 
using a reader study. 
• To estimate specificity of stationary head CT for the detection of a fracture 
using a reader study. 
• To evaluate the reader confidence for the stationary head CT in detecting 
hemorrhage or fracture as compared to a conventional CT.  
 
2.3 
Outcome Variables 
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 the clinical assessment at 3 months as the gold 
standard. The interpretation of the clinical data will be made by the study PI 
(Brian D. Sindelar). A neuroradiologist (J. Keith Smith) may re-interpret images 
as necessary at the request of the PI.   
 
3.0 
PATIENT ELIGIBILITY 
3.1 
Inclusion Criteria 
3.1.1 18 years of age or older 
3.1.2 Medically stable ambulatory patient (outpatient) with head trauma or known 
intracranial hemorrhage (subdural or intraparenchymal) or skull fractures 
3.1.3 Patient has undergone conventional head CT imaging at UNC hospitals within the 
past 5 days or will undergo a CT scan of the head 
3.1.4 Willing and able to provide written informed consent 
3.2 
Exclusion Criteria 
3.2.1 Unable to provide consent 
3.2.2 Severe claustrophobia 
4.0 
STUDY PLAN 

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Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
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4.1 
STUDY SCHEMA 
 
 
4.2 
Study Procedures 
4.2.1 Enrollment/Recruitment 
We will recruit 50 medically stable patients who have undergone conventional 
head CT imaging for imaging within 5 days with the s-HCT system. We will 
recruit medically stable patients with head trauma or known intracranial 
hemorrhage (subdural or intraparenchymal) or skull fractures with recent CT 
imaging. Subjects will be serially recruited with the assistance of the neurosurgery 
department at our institution. If the attending physician deems a patient stable, a 
clinical coordinator will obtain informed consent from the subject.  If the 
coordinator has questions about patient competency to provide informed consent, 
a qualified healthcare provider will make the appropriate determination.  In some 
cases, patients may have recently suffered from a trauma and may be seen for a 
follow up appointment.  In these cases, the s-HCT scan may be obtained prior to 
the follow up head CT as long as it meets the 5 day window. 
 
Given our high institutional volume of ruptured brain aneurysms and our Level I 
trauma status, we do not anticipate difficulty with patient volume. 
 
Participants’ involvement is limited to one single visit, which will include the s-
HCT scan.  No follow-up is necessary.   
4.2.2 Research Imaging Procedures 
Once the study participant has signed the consent forms, either the research 
coordinator or the radiology technologist will escort them to the study room for 
the imaging exam.  
 
The participant will not wear any head jewelry during the scan.  The participant 
will have the s-HCT scan performed in a similar manner as the clinical head CT. 
They will lie on the patient table, and the technologist will position their head in 
the s-HCT system. Once positioned, the total scan time is a few minutes. The 
length of time for the positioning and examination may vary, but it is expected 
that the entire imaging procedure will take about 5-10 minutes, including the 
positioning time.  
4.2.3 Medical Record Abstraction 
Data will be collected from participants and their medical records, as applicable.  
We will follow participants’ medical records for 3 months following imaging to 
Screening & 
Enrollment 
s-HCT 
Return to 
clinical Care 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
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9 
assess for treatment decisions and clinical gold standard as to the presence of a 
hemorrhage or fracture.   
 
We will document clinical information using the TBI common data elements29 
(CDE) and a local data research electronic data capture system (REDCap). 
However, as these patients and their imaging data are obtained in a sub-acute 
setting and from a variety of pathologies, we will not utilize the full TBI CDE 
data documentation. Specifically, we will utilize the General Core, 
Demographics, and Injury Presentation. Our clinical scans adhere to the Imaging 
Diagnostic Imaging Parameters for MRI and Protocols for MRI and CT 
Guidelines. 
4.2.4 Reader Study  
All images will be de-identified before inclusion within a reader study. We will 
perform a reader study with physician readers comparing the acquired imaging s-
HCT images and conventional head CT. We hypothesize that the sensitivity of 
reader’s in the interpretation of images from the s-HCT system will be similar to 
that of the conventional CT imaging. The paired images will be presented to five 
readers. Readers will be blinded to which imaging modality is being presented.  
There is, however, readers may be able to distinguish the imaging modality based 
on the images.  Our readers will consist of a trauma surgeon, neurosurgeon or 
neuro radiologist and non-study radiologists to better reflect the different clinical 
backgrounds that may be available in a Role 3 environment. 
 
Reconstructed images will be presented in a clinical PACS environment. The 
readers will be presented images for interpretation in a two-phase study with an 
interim washout period. First, for each patient, either the s-HCT or conventional 
head CT images will be presented in random order, and the readers will be asked 
to identify the presence of hemorrhage (yes/no), the location of the pathology if 
present and confidence level (0 through 100% in 10% increments). Readers will 
also be asked to perform interpretations with the appropriate Imaging CT CDE, 
including the Marshall CT TBI classification code 30, hemorrhage and fracture 
elements. Four weeks later, the other modality for each patient will be presented 
in a random order and the same scoring obtained.  
 
The scoring scheme used by readers will include 1) hemorrhage (yes/no) with 
confidence 0-100% in 10% increments, 2) fracture (yes/no) with confidence 0-
100% in 10% increments, 3) streak artifacts (yes/no), and ) other artifacts 
(yes/no). 
4.3 
Time and Events Table 
 
 
 
Pre-study 
Imaging 
Visit 
Conclusion 
of all data 
collection 
Informed Consent 
 
X 
 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
10 
SOC Imaging 
X 
 
 
Research Imaging 
 
X 
 
Medical Record 
Abstraction/ 
Questionnaires 
 
X 
 
Reader Study 
 
 
X 
 
5.0 
INVESTIGATIONAL DEVICE 
5.1 
Investigational Device Description 
The basic system geometry requirements includes a 25 cm field-of-view and the 
capability of scanning a 30 cm axial field of view. The approximate power is 1.2 
kW. Reconstruction time is estimated to be significantly less than one minute for 
40 slices. 
 
The research images will not be interpreted or analyzed for clinical decisions 
related to the patient.  As such, this study will request that the IRB make a 
determination that this study is no greater than minimal risk. This study meets all 
the requirements for an NSR determination including: 
• The device will not be implanted. 
• The device is not intended to support or sustain human life. 
• The device is not being used of substantial importance in diagnosing, 
curing, mitigating, or treating disease. 
• The device does not present a potential for serious risk to health, safety, or 
welfare of a subject. 
5.2 
Expected Risks 
Radiation dose will be no more than a conventional head CT (2 mSv), which is 
considered negligible risk by the Radiation Safety Committee and Institutional 
Review Board at our institution. All appropriate Institutional Review Board, 
Electrical and Radiation safety approvals will be obtained prior to the 
commencement of imaging. 
 
Practically, we anticipate that many of the scans will be obtained in a subacute 
post-trauma / event time frame, to insure there is no additional risk to the subjects 
due to subject transport.  
 
Claustrophobia (fear of being enclosed in tight spaces) may occur during the 
procedure and the noise of the x-ray machine could be uncomfortable. Some 
people may feel discomfort lying on the CT table or may experience anxiety 
while the table slides in and out of the CTscanner. 
6.0 
UNANTICIPATED CONCERNS (DEVICES) 

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6.1 
Unanticipated Adverse Device Effect (UADE) 
The investigational device exemption (IDE) regulations define an unanticipated 
adverse device effect (UADE) as “any serious adverse effect on health or safety 
or any life-threatening problem or death caused by, or associated with, a device, if 
that effect, problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious problem 
associated with a device that relates to the rights, safety, or welfare of subjects” 
(21 CFR 812.3(s)). 
6.2 
Unanticipated Problems (UP) 
As defined by UNC’s IRB, unanticipated problems involving risks to study 
subjects refers to any incident, experience, or outcome that: 
• Is unexpected (in terms of nature, severity, or frequency) given (a) the 
research procedures that are described in the protocol-related documents, 
such as the IRB-approved research protocol and informed consent 
document; and (b) the characteristics of the subject population being 
studied; 
• Is related or possibly related to a subject’s participation in the research; 
and  
• Suggests that the research places subjects or others at a greater risk of 
harm (including physical, psychological, economic, or social harm) related 
to the research than was previously known or recognized. 
6.3 
Reporting 
6.3.1 UADEs 
UADEs must be reported by the clinical investigator to the reviewing IRB, as 
described below:  
 
For this device study, investigators are required to submit a report of a UADE to 
the FDA, the manufacturer of the device and the UNC IRB as soon as possible, 
but in no event later than 10 working days after the investigator first learns of the 
event (§ 812.150(a)(1)), using the MedWatch Form 3500A.   The sponsor- 
investigator  must immediately conduct an evaluation of a UADE and must report 
the results of the evaluation to FDA, the UNC IRB, and participating investigators 
within 10 working days after the sponsor-investigator first receives notice of the 
effect (§§ 812.46(b), 812.150(b)(1)).  
 
For this device study, we will submit a report of a UADE to the manufacturer and 
the IRB as soon as possible, but no later than 10 working days after the 
investigators first learn of the event. 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
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6.3.2 UP 
Any events that meet the criteria for “Unanticipated Problems” as defined by 
UNC’s IRB must be reported by the Study Coordinator using the IRB’s web-
based reporting system.   
 
Any unanticipated problem that occurs during the conduct of this study and that 
meets at least the first two criteria listed in section 6.2 must be reported to the 
UNC IRB using the IRB’s web-based reporting system.  
 
  
7.0 
STATISTICAL CONSIDERATIONS 
7.1 
Study Design 
This is a single arm, non-randomized study to calculate sensitivity and specificity 
for stationary head CT for the detection of a hemorrhage and fracture using a 
reader study.    
7.2 
Sample Size  Rationale 
For an equivalence test of the difference between conventional HCT and s-HCT, a 
sample size of 25 subjects achieves at least 80.0% power at a significance level of 
0.050 when the lower equivalence difference is -0.237, the upper equivalence 
difference is 0.237, sensitivity of conventional HCT and s-HCT is assumed to be 
90.0%, and the proportion of concordant pairs is assumed to be 0.900.34-37 
 
 
A table of power calculations for various values of N and various equivalence differences 
is shown below. For reference, a recent review of the sensitivity of skull radiographs to 
intracerebral hemorrhage gives a sensitivity range of 3 to 75%. 38    
 
 
Power  
N 
Lower Equivalence 
Upper Equivalence 
CHCT Sensitivity 
s-HCT Sensitivity 
Concordance 
Alpha 
0.99969 
25 
-0.4 
0.4 
0.9 
0.9 
0.9 
0.05 
1 
50 
-0.4 
0.4 
0.9 
0.9 
0.9 
0.05 
1 
75 
-0.4 
0.4 
0.9 
0.9 
0.9 
0.05 
1 
100 
-0.4 
0.4 
0.9 
0.9 
0.9 
0.05 
0.99906 
25 
-0.38 
0.38 
0.9 
0.9 
0.9 
0.05 
1 
50 
-0.38 
0.38 
0.9 
0.9 
0.9 
0.05 
1 
75 
-0.38 
0.38 
0.9 
0.9 
0.9 
0.05 
1 
100 
-0.38 
0.38 
0.9 
0.9 
0.9 
0.05 
0.9974 
25 
-0.36 
0.36 
0.9 
0.9 
0.9 
0.05 
1 
50 
-0.36 
0.36 
0.9 
0.9 
0.9 
0.05 
1 
75 
-0.36 
0.36 
0.9 
0.9 
0.9 
0.05 
1 
100 
-0.36 
0.36 
0.9 
0.9 
0.9 
0.05 
0.99346 
25 
-0.34 
0.34 
0.9 
0.9 
0.9 
0.05 
1 
50 
-0.34 
0.34 
0.9 
0.9 
0.9 
0.05 
1 
75 
-0.34 
0.34 
0.9 
0.9 
0.9 
0.05 

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1 
100 
-0.34 
0.34 
0.9 
0.9 
0.9 
0.05 
0.98497 
25 
-0.32 
0.32 
0.9 
0.9 
0.9 
0.05 
0.99999 
50 
-0.32 
0.32 
0.9 
0.9 
0.9 
0.05 
1 
75 
-0.32 
0.32 
0.9 
0.9 
0.9 
0.05 
1 
100 
-0.32 
0.32 
0.9 
0.9 
0.9 
0.05 
0.96829 
25 
-0.3 
0.3 
0.9 
0.9 
0.9 
0.05 
0.99996 
50 
-0.3 
0.3 
0.9 
0.9 
0.9 
0.05 
1 
75 
-0.3 
0.3 
0.9 
0.9 
0.9 
0.05 
1 
100 
-0.3 
0.3 
0.9 
0.9 
0.9 
0.05 
0.93837 
25 
-0.28 
0.28 
0.9 
0.9 
0.9 
0.05 
0.99979 
50 
-0.28 
0.28 
0.9 
0.9 
0.9 
0.05 
1 
75 
-0.28 
0.28 
0.9 
0.9 
0.9 
0.05 
1 
100 
-0.28 
0.28 
0.9 
0.9 
0.9 
0.05 
0.88916 
25 
-0.26 
0.26 
0.9 
0.9 
0.9 
0.05 
0.99902 
50 
-0.26 
0.26 
0.9 
0.9 
0.9 
0.05 
1 
75 
-0.26 
0.26 
0.9 
0.9 
0.9 
0.05 
1 
100 
-0.26 
0.26 
0.9 
0.9 
0.9 
0.05 
0.81472 
25 
-0.24 
0.24 
0.9 
0.9 
0.9 
0.05 
0.99623 
50 
-0.24 
0.24 
0.9 
0.9 
0.9 
0.05 
0.99996 
75 
-0.24 
0.24 
0.9 
0.9 
0.9 
0.05 
1 
100 
-0.24 
0.24 
0.9 
0.9 
0.9 
0.05 
0.71079 
25 
-0.22 
0.22 
0.9 
0.9 
0.9 
0.05 
0.98761 
50 
-0.22 
0.22 
0.9 
0.9 
0.9 
0.05 
0.99969 
75 
-0.22 
0.22 
0.9 
0.9 
0.9 
0.05 
0.99999 
100 
-0.22 
0.22 
0.9 
0.9 
0.9 
0.05 
0.57643 
25 
-0.2 
0.2 
0.9 
0.9 
0.9 
0.05 
0.96515 
50 
-0.2 
0.2 
0.9 
0.9 
0.9 
0.05 
0.99816 
75 
-0.2 
0.2 
0.9 
0.9 
0.9 
0.05 
0.99993 
100 
-0.2 
0.2 
0.9 
0.9 
0.9 
0.05 
 
Here is a plot as a function of N and the equivalence difference. 
 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
14 
 
 
All power calculations were conducted using PASS 2020 software. 
 
7.3 
Data Analysis Plans 
We will estimate the sensitivity and specificity from the two modalities 
To compare the results from the two imaging modalities, we will adopt the mixed 
effect ANOVA based on the Dorfman-Berbaum-Metz method. To test the main 
hypothesis, the F-test statistic from the model parameter estimates will be used to 
compare the mean sensitivity / specificity metrics between the conventional head 
CT and the simulated solid-state head CT. Possible interactions between the 
modalities and the readers and the hemorrhage type/locations will also be 
included and tested for statistical significance. Sensitivity and specificity on the 
presence of clinically actionable pathology will also be assessed, based on 
consensus read of the conventional imaging.    
 
For each confidence comparison, the average confidence scores and the 
corresponding standard deviations will be reported. To test whether the mean 
Power vs D0.L by N
Ps=0.90 D1=0.00 P00+P11=0.90 Alpha=0.05 2-Sided Equivalence Test
D0.L
-0.40
-0.35
-0.30
-0.25
-0.20
0.5
0.6
0.7
0.8
0.9
1.0
N
25
50
75
100

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
15 
confidence score is larger than zero, a linear mixed effect will be used to analyze 
data, where the outcome variable is the confidence scores collected in this study 
and only a grand mean parameter is in the independent list. Additionally, a 
random intercept is used in the model to account for the correlation among 
readers when reading the images from the same patient. The Wald’s test based on 
model fit will be used to test whether the grand mean parameter is larger than 
zero. When the p-value from this test is less than 0.05, it will be concluded that 
there exists significant evidence that readers have more confidence with the s-
HCT modality compared to the other modality. ROC curves will be evaluated. 
 
We will also descriptively compare inter-reader agreement by modality for image 
quality, confidence in image interpretation, presence and location of hemorrhage, 
and presence and location of fractures by computing and reporting Fleiss’ kappa.    
 
All statistical estimates of population parameters will be tabulated along with 
corresponding confidence intervals (CIs) and/or standard errors (SEs) to convey 
levels of precision / imprecision.  Hypothesis tests that are deemed to be not 
statistically significant will be indicated as inconclusive.  
8.0 
STUDY MANAGEMENT 
8.1 
Institutional Review Board (IRB) Approval and Consent 
It is expected that the IRB will have the proper representation and function in 
accordance with federally mandated regulations.  The IRB should approve the 
consent form and protocol. 
 
In obtaining and documenting informed consent, the investigator should comply 
with the applicable regulatory requirement(s), and should adhere to Good Clinical 
Practice (GCP) and to ethical principles that have their origin in the Declaration 
of Helsinki. 
 
 
 
Before recruitment and enrollment onto this study, the patient will be given a full 
explanation of the study and will be given the opportunity to review the consent 
form. Each consent form must include all the relevant elements currently required 
by the FDA Regulations and local or state regulations. Once this essential 
information has been provided to the patient and the investigator is assured that 
the patient understands the implications of participating in the study, the patient 
will be asked to give consent to participate in the study by signing an 
IRB-approved consent form. 
 
Prior to a patient’s participation in the trial, the written informed consent form 
should be signed and personally dated by the patient and by the person who 
conducted the informed consent discussion. 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
16 
8.2 
Registration Procedures 
Study participants will be registered into REDCap®, a web based clinical 
research platform by one of the Study Coordinators. 
8.3 
Data Management  
8.3.1 Data Collection and Documentation  
We will utilize TBI CDE to document the imaging data of patients for data 
analysis purposes. The online REDCap software system provided by UNC’s 
TraCS Institute will be used for data collection and management, which will 
ensure that data collected are consistent and follow standardized coding. Data will 
be entered into REDCap by the study coordinator within 5 business days. 
 
All data requested on the case report forms (CRFs) will be recorded by the study 
coordinator.  All missing data will be explained.  If a space on the CRF is left 
blank because the procedure was not done or the question was not asked, the 
study team will write “N/D”.  If the item is not applicable to the individual case, 
the study team will write “N/A”.  Every attempt will be made to ensure that there 
is as little missing data as possible including reminder phone calls and follow-up 
phone calls, if a subject misses a visit.  However, this study is limited to a single 
subject visit so missing values will be minimal.  If subjects withdraw, the reason 
for subject withdrawal will be documented in the study database.  
8.3.2 Data Quality  
The study team will adhere to the Department of Radiology Internal Monitoring 
and Quality Assurance Standard Operating Procedures to ensure data quality, 
completeness, and accuracy are maintained for this study. The Department of 
Radiology’s Internal Quality Assurance program will verify a random selection of 
at least 25% of all source documents for accuracy and completeness.  
8.3.3 Data and Safety Monitoring  
This study will not have a data and safety monitoring board. The principal 
investigator will maintain overall responsibility for data and safety monitoring.  
 
Safety Monitoring will be performed by a licensed physician who is not a study 
investigator. Medical monitoring will occur at least annually for the duration of 
this study.   
The research coordinator will monitor the study files on a monthly basis to ensure 
the appropriate regulatory and IRB documentations are on file and up to date. The 
research coordinator will also be responsible for ensuring proper study 
documentation in order to verify compliance with Institutional policy, IRB, FDA 
and GCP guidelines in the following areas: Informed consent, Protocol, Source 
Documents and Electronic Case Report Forms. 
 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
17 
The principal investigator and research coordinator will be responsible for 
maintaining IRB correspondence. IRB approved forms maintained, as part of the 
study will include the subject consent form and the HIPAA authorization form. 
 
The investigator will permit study-related monitoring, audits, and inspections by 
the Research Quality Assurance Office, IRB, and government regulatory bodies, 
of all study related documents (e.g. source documents, regulatory documents, data 
collection instruments, study data etc.).  The investigator will ensure the 
capability for inspections of applicable study-related facilities (e.g. pharmacy, 
diagnostic laboratory, etc.) 
8.3.4 Data archival and data sharing 
Data from this study may be submitted to the Federal Interagency Traumatic 
Brain Injury (FITBIR) informatics system. FITBIR is a computer system run by 
the National Institutes of Health that allows researchers studying traumatic brain 
injury to collect and share information with each other. 
8.4 
Adherence to the Protocol 
Except for an emergency situation in which proper care for the protection, safety, 
and well-being of the study patient requires alternative treatment, the study shall 
be conducted exactly as described in the approved protocol.   
8.4.1 Emergency Modifications 
UNC investigators may implement a deviation from, or a change of, the protocol 
to eliminate an immediate hazard(s) to trial subjects without prior UNC’s 
IRB/IEC approval/favorable opinion.   
 
For any such emergency modification implemented, an IRB modification form 
must be completed by UNC Research Personnel within five (5) business days of 
making the change.   
8.4.2 Protocol Deviations/Violations 
According to UNC’s IRB, a protocol deviation is any unplanned variance from an 
IRB approved protocol that:  
• Is generally noted or recognized after it occurs 
• Has no substantive effect on the risks to research participants 
• Has no substantive effect on the scientific integrity of the research plan 
or the value of the data collected  
• Did not result from willful or knowing misconduct on the part of the 
investigator(s).  
 
An unplanned protocol variance is considered a violation if the variance meets 
any of the following criteria:  
• Has harmed or increased the risk of harm to one or more research 
participants. 
• Has damaged the scientific integrity of the data collected for the study. 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
18 
• Results from willful or knowing misconduct on the part of the 
investigator(s). 
• Demonstrates serious or continuing noncompliance with federal 
regulations, State laws, or University policies. 
 
If a deviation or violation occurs please follow the guidelines below: 
 
Protocol Deviations: Deviations should be summarized and reported to the IRB 
at the time of continuing review. 
 
Protocol Violations: Violations should be reported by UNC personnel within one 
(1) week of the investigator becoming aware of the event using the same IRB 
online mechanism used to report Unanticipated Problems.   
 
Unanticipated Problems: 
Any events that meet the criteria for “Unanticipated Problems” as defined by 
UNC’s IRB must be reported by the study team using the IRB’s web-based 
reporting system.   
8.5 
Amendments to the Protocol 
Should amendments to the protocol be required, the amendments will be 
originated and documented by the Principal Investigator at UNC.  It should also 
be noted that when an amendment to the protocol substantially alters the study 
design or the potential risk to the patient, a revised consent form might be 
required.   
 
The written amendment, and if required the amended consent form, must be sent 
to UNC’s IRB for approval prior to implementation.  
8.6 
Record Retention 
Study documentation includes all eCRFs, data correction forms or queries, source 
documents, essential correspondence, monitoring logs/letters, and regulatory 
documents (e.g., protocol and amendments, IRB correspondence and approval, 
signed patient consent forms). 
 
Source documents include all recordings of observations or notations of clinical 
activities and all reports and records necessary for the evaluation and 
reconstruction of the clinical research study. 
 
Government agency regulations and directives require that all study 
documentation pertaining to the conduct of a clinical trial must be retained by the 
study investigator.  In the case of a study with a drug seeking regulatory approval 
and marketing, these documents shall be retained for at least two years after the 
last approval of marketing application in an International Conference on 
Harmonization (ICH) region.  In all other cases, study documents should be kept 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
19 
on file until three years after the completion and final study report of this 
investigational study. 
8.7 
Obligations of Investigators 
The Principal Investigator is responsible for the conduct of the clinical trial at the 
site in accordance with Title 21 of the Code of Federal Regulations and/or the 
Declaration of Helsinki.  The Principal Investigator is responsible for personally 
overseeing the treatment of all study participants.  The Principal Investigator must 
assure that all study site personnel, including sub-investigators and other study 
staff members, adhere to the study protocol and all FDA/GCP/NCI regulations 
and guidelines regarding clinical trials both during and after study completion. 
9.0 
PLANS FOR PUBLICATION 
Study results will be submitted to a peer-reviewed journal for publication. This 
study will also be listed on Clinicaltrials.gov and study results will be posted in 
accordance with appropriate regulations and ICJME requirements.  
 
Neither the complete nor any part of the results of the study carried out under this 
protocol will be published or passed on to any third party without the consent of 
the study sponsor-investigator. Any investigator involved with this study will be 
obligated to provide the sponsor-investigator with complete results and all data 
derived from the study. 
10.0 REFERENCES 
             
1. Rumboldt Z, Huda W, All JW. Review of Portable CT with Assessment of a 
Dedicated Head CT Scanner. AJNR Am J Neuroradiol. 2009 Oct 1;30(9):1630–
1636. 
 
2. Samson K. A Mobile Stroke CT Unit Cuts tPA Administration Times By One-
Third. Neurol Today. 2012 Dec;12(24):1. 
 
3. Rigauts H, Marchal G, Baert AL, Hupke R. Initial experience with volume CT 
scanning. J Comput Assist Tomogr. 1990 Aug;14(4):675–682. PMID: 2370371 
 
4. Segars WP, Sturgeon G, Mendonca S, Grimes J, Tsui BMW. 4D XCAT phantom 
for multimodality imaging research. Med Phys. 2010 Sep;37(9):4902–4915. PMID: 
20964209 
 
5. Bian J, Han X, Sidky EY, Cao G, Lu J, Zhou O, Pan X. Investigation of Sparse 
Data Mouse Imaging Using Micro-CT with a Carbon-Nanotube-Based X-ray 
Source. Tsinghua Sci Technol. 2010 Feb 1;15(1):74–78. PMID: 20582237 
 
6. Yue GZ, Qiu Q, Gao B, Cheng Y, Zhang J, Shimoda H, Chang S, Lu JP, Zhou O. 
Generation of continuous and pulsed diagnostic imaging x-ray radiation using a 
carbon-nanotube-based field-emission cathode. Appl Phys Lett. 2002;81:355. 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
20 
 
7. Lee YZ, Burk LM, Wang K, Cao G, Volmer J, Lu J, Zhou O. Prospective 
Respiratory Gated Carbon Nanotube Micro Computed Tomography. Acad Radiol. 
2011 May;18(5):588–593. 
 
8. Zhang J, Yang G, Cheng Y, Gao B, Qiu Q, Lee YZ, Lu JP, Zhou O. Stationary 
scanning x-ray source based on carbon nanotube field emitters. Appl Phys Lett. 
2005;86(18):184104. 
 
9. Tucker AW, Lu J, Zhou O. Dependency of image quality on system configuration 
parameters in a stationary digital breast tomosynthesis system. Med Phys. 2013 
Mar;40(3):031917. PMCID: PMC3600660 
 
10. Shan J, Chtcheprov P, Tucker AW, Lee YZ, Wang X, Foos D, Heath MD, Lu J, 
Zhou O. Stationary chest tomosynthesis using a CNT x-ray source array. 2013 
[cited 
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86680E–86680E–12. 
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from: 
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11. Maltz JS, Sprenger F, Fuerst J, Paidi A, Fadler F, Bani-Hashemi AR. Fixed gantry 
tomosynthesis system for radiation therapy image guidance based on a multiple 
source x-ray tube with carbon nanotube cathodes. Med Phys. 2009 
May;36(5):1624–1636. PMID: 19544779 
 
12. Pan X, Sidky EY, Vannier M. Why do commercial CT scanners still employ 
traditional, filtered back-projection for image reconstruction? Inverse Probl. 2009 
Dec;25(12):123009. 
 
13. Siltanen S, Kolehmainen V, J rvenp S, Kaipio JP, Koistinen P, Lassas M, Pirttil J, 
Somersalo E. Statistical inversion for medical x-ray tomography with few 
radiographs: I. General theory. Phys Med Biol. 2003 May 21;48(10):1437–1463. 
 
14. Lo SC, Lou SL, Mun SK. Projection domain compensation of missing angles for 
fan-beam CT reconstruction. Comput Med Imaging Graph Off J Comput Med 
Imaging Soc. 1992 Aug;16(4):259–269. PMID: 1511399 
 
15. Herman GT, Lent A, Rowland SW. ART: Mathematics and applications: A report 
on the mathematical foundations and on the applicability to real data of the 
algebraic reconstruction techniques. J Theor Biol. 1973 Nov 5;42(1):1–32. 
16. Huang J, Zhang Y, Ma J, Zeng D, Bian Z, Niu S, Feng Q, Liang Z, Chen W. 
Iterative Image Reconstruction for Sparse-View CT Using Normal-Dose Image 
Induced Total Variation Prior. PLoS ONE. 2013 Nov 18;8(11):e79709. 
17. Liu Y, Liang Z, Ma J, Lu H, Wang K, Zhang H, Moore W. Total Variation-Stokes 
Strategy for Sparse-View X-ray CT Image Reconstruction. IEEE Trans Med 
Imaging. 2014 Mar;33(3):749–763. 
 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
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18. Niu S, Gao Y, Bian Z, Huang J, Chen W, Yu G, Liang Z, Ma J. Sparse-view x-ray 
CT reconstruction via total generalized variation regularization. Phys Med Biol. 
2014 Jun 21;59(12):2997. 
 
19. Abbas S, Lee T, Shin S, Lee R, Cho S. Effects of sparse sampling schemes on image 
quality in low-dose CT. Med Phys. 2013 Nov 1;40(11):111915. 
 
20. Bian J, Siewerdsen JH, Han X, Sidky EY, Prince JL, Pelizzari CA, Pan X. 
Evaluation of sparse-view reconstruction from flat-panel-detector cone-beam CT. 
Phys Med Biol. 2010 Nov 21;55(22):6575–6599. PMID: 20962368 
 
21. Sidky EY, Kao C-M, Pan X. Accurate image reconstruction from few-views and 
limited-angle data in divergent-beam CT. J X-Ray Sci Technol. 2006 Jan 
1;14(2):119–139. 
 
22. Gonzales B, Spronk D, Cheng Y, Zhang Z, Pan X, Beckmann M, Zhou O, Lu J. 
Rectangular computed tomography using a stationary array of CNT emitters: 
initial experimental results. 2013 [cited 2014 Jun 12]. p. 86685K–86685K–8. 
Available from: http://dx.doi.org/10.1117/12.2008030 
 
23. Bushberg JT, Seibert JA, Jr EML, Boone JM. The Essential Physics of Medical 
Imaging. 2.00. Lippincott Williams & Wilkins; 2001. 
 
24. Robb RA, Lent AH, Gilbert BK, Chu A. The dynamic spatial reconstructor: a 
computed tomography system for high-speed simultaneous scanning of multiple 
cross sections of the heart. J Med Syst. 1980;4(2):253–288. PMID: 7217811 
 
25. Bian J, Siewerdsen JH, Han X, Sidky EY, Prince JL, Pelizzari CA, Pan X. 
Evaluation of sparse-view reconstruction from flat-panel-detector cone-beam CT. 
Phys Med Biol. 2010 Nov;55(22):6575–6599. 
 
26. Jennings (INVITED) RJ. Computational Methods for the Design of Test Objects 
and Tissue Substitutes for Radiologic Applications. Radiat Prot Dosimetry. 1993 
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27. Ruhrnschopf E-P, Klingenbeck and K. A general framework and review of scatter 
correction methods in cone beam CT. Part 2: Scatter estimation approaches. Med 
Phys. 2011;38(9):5186–5199. 
 
28. Wu G, Inscoe C, Calliste J, Lee YZ, Zhou O, Lu J. Adapted fan-beam volume 
reconstruction for stationary digital breast tomosynthesis. 2015 [cited 2015 Jun 5]. 
p. 94123J–94123J–10. Available from: http://dx.doi.org/10.1117/12.2081931 
 
29. Hicks R, Giacino J, Harrison-Felix C, Manley G, Valadka A, Wilde EA. Progress 
in Developing Common Data Elements for Traumatic Brain Injury Research: 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
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Version Two – The End of the Beginning. J Neurotrauma. 2013 Nov 
15;30(22):1852–1861. PMCID: PMC3814822 
 
30. Marshall LF, Marshall SB, Klauber MR, Van Berkum Clark M, Eisenberg H, Jane 
JA, Luerssen TG, Marmarou A, Foulkes MA. The diagnosis of head injury requires 
a classification based on computed axial tomography. J Neurotrauma. 1992 Mar;9 
Suppl 1:S287-292. PMID: 1588618 
 
31. Cao G, Calderon-Colon X, Burk L, Lee YZ, Sultana S, Lu J, Zhou O. Desktop 
micro-CT with a nanotube field emission x-ray source for high-resolution cardiac 
imaging. In: Samei E, Pelc NJ, editors. 2010 [cited 2015 Mar 27]. p. 76222B–
76222B–8. Available from: 
http://proceedings.spiedigitallibrary.org/proceeding.aspx?articleid=1339828 
 
32. Calliste J, Tucker AW, Gidcumb E, Kuzmiak CM, Lu J, Zhou O, Lee YZ. Initial 
clinical evaluation of stationary digital breast tomosynthesis. In: Hoeschen C, 
Kontos D, Flohr TG, editors. Proc SPIE [Internet]. 2015 [cited 2015 Mar 27]. p. 
941228. Available from: 
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33. Tucker AW, Calliste J, Gidcumb EM, Wu J, Kuzmiak CM, Hyun N, Zeng D, Lu J, 
Zhou O, Lee YZ. Comparison of a Stationary Digital Breast Tomosynthesis System 
to Magnified 2D Mammography Using Breast Tissue Specimens. Acad Radiol. 
2014 Dec;21(12):1547–1552. 
 
34. Lewis, J.A. 1999. 'Statistical principles for clinical trials (ICH E9) an introductory 
note on an international   guideline.' Statistics in Medicine, 18, pages 1903-1942. 
 
35. Liu, J., Hsueh, H., Hsieh, E., and Chen, J.J. 2002. 'Tests for equivalence or non-
inferiority for paired binary data',   Statistics in Medicine, Volume 21, pages 231-
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36. Nam, Jun-mo. 1997. 'Establishing equivalence of two treatments and sample size 
requirements in matched-pairs   design', Biometrics, Volume 53, pages 1422-1430. 
 
37. Nam, Jun-mo and Blackwelder, W.C. 2002. 'Analysis of the ratio of marginal 
probabilities in a matched-pair   setting', Statistics in Medicine, Volume 21, pages 
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38. Hofman P, Nelemans P, Kemerink G, Wilmink J. Value of radiological diagnosis 
of skull fracture in the management of mild head injury:  meta-analysis. J Neurol 
Neurosurg Psychiatry. 2000 Apr;68(4):416–422. PMCID: PMC1736859 
 
11.0 APPENDICES 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
23 
 
READER STUDY: Evaluation of a Carbon Nanotube Enabled Solid-
State Head CT 
 
Subject ID:______________ 
Reader:_________________ 
Date:___________________ 
 
 
1) Hemorrhage: _____ Yes     _____ No 
 
Hemorrhage confidence 0-100% in 10% increments: ____________% 
 
Location (lobe):______________________________________ 
 
2) Fracture: _____ Yes     _____ No  
Fracture confidence 0-100% in 10% increments: ____________% 
Location (bone):______________________________________ 
 
 
Rotterdam CT Scale using sHCT 
 
1. Basal cisterns 
0 
1 
2 
Normal 
Compressed Absent 
 
2. Midline Shift 
0 
1 
No Shift or Shift ≤ 5 mm 
Shift > 5mm 
 
3. Epidural Mass Lesion 
0 
1 
Present 
Absent 
 
4. Intraventricular blood or traumatic Subarachnoid hemorrhage (tSAH) 
0 
1 
Absent 
Present 
 
5. Sum score (+1): _______________________ 
 
6. Image Quality 
 
1 
2 
3 
4 
5 
Non-
interpretable; 
Artifact 
present; 
Artifact 
present; 
moderately 
interferes with 
Artifact 
present; mildly 
interferes with 
interpretability 
Artifact 
present; does 
not interfere 
with 
High quality, 
no artifacts 

UNIVERSITY OF NORTH CAROLINA AT CHAPEL HILL 
Non-Oncology Imaging Protocol Template 
DEPARTMENT OF RADIOLOGY 
 
February 2017 
 
24 
severely 
interferes with 
interpretability 
interpretability 
interpretability 
 
 
7. Streak Artifacts: _____ Yes     _____ No 
 
 
Location (lobe):______________________________________ 
 
8. Other artifacts: _____ Yes     _____ No  
 
Location (lobe or 
bone):______________________________________ 
 
 
 
Reader comments regarding the images: 
 
 _______________________________________________________________ 
 
 
 
 
Reader comments regarding artifacts:  
 
 
 
________________________________________________________________ 
_______________