Clinical Evaluation of a Dual Energy CT System

Study Overview
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Brief Summary
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The main purpose of this study is to collect clinical raw scan data and Scanner user feedback using dual energy CT (computed tomography) scan modes on the investigational CT scanner. Additionally, image quality using prototype reconstruction algorithms that are in development will be evaluated and compared to standard-of-care images acquired with regulatory cleared diagnostic CT scanners for feasibility assessment and engineering development. Compared to standard clinical single energy (kilovolt,kV) scanning, dual energy (kV) scanning s provides more information about the material composition of the scanned patient and may allow for improved tissue, tumor characterization, and improved image quality.

Official Title
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Clinical Evaluation of a Dual Energy CT System

Conditions
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General CT Imaging

Intervention / Treatment
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* Device: GE Healthcare Revolution CT Scanner (CT Scanner)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Who are 18 year of age or older; Able to sign and date the informed consent form; AND Who have in the past year undergone a clinically-indicated CT exam of the head, neck, chest, abdomen, pelvis, or extremities Exclusion Criteria: Who are pregnant or lactating; Who were previously enrolled in this study; For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents; For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel; Who are in need of urgent or emergent care; Diabetic patients on metformin (Glucophage) Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; AND Who are unwilling to have GEHC personnel present for the CT exam

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GE Healthcare CT Revolution (CT scanner)<br>Each subject will be scanned twice: the first time will be the subjects' clinically indicated CT exam and the second scan will be performed on the GE Healthcare CT Revolution (CT scanner) both scans will will be obtained. | Device: GE Healthcare Revolution CT Scanner (CT Scanner)<br>* Raw CT Scan Data<br>* Other names: CT scanner;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Raw CT Scan Data | No outcome assessment is currently planned. Up to 60 subjects will be scanned using GE Healthcare's Revolution CT scanner for future engineering and regulatory purposes. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image Quality assessment | Likert Scale to assess image quality | 3 months |