Clinical Evaluation of a Dual Energy CT System

Not Applicable

Completed

• Conditions: General CT Imaging
• Interventions: Device: GE Healthcare Revolution CT Scanner (CT Scanner)

• Registration Number: NCT02731937
• Lead Sponsor: GE Healthcare

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-24
• Study Start: 2016-04
• Study First Submitted QC: 2016-04-06
• Study First Posted: 2016-04-08
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Who are 18 year of age or older;
2. Able to sign and date the informed consent form; AND
3. Who have in the past year undergone a clinically-indicated CT exam of the head, neck, chest, abdomen, pelvis, or extremities

Exclusion Criteria

1. Who are pregnant or lactating;
2. Who were previously enrolled in this study;
3. For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents;
4. For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
5. Who are in need of urgent or emergent care;
6. Diabetic patients on metformin (Glucophage)
7. 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
8. Who are unwilling to have GEHC personnel present for the CT exam

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GE Healthcare CT Revolution (CT scanner)	GE Healthcare Revolution CT Scanner (CT Scanner)	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.

Primary Outcome Measures

Name	Time	Method
Raw CT Scan Data	3 months	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.

Secondary Outcome Measures

Name	Time	Method
Image Quality assessment	3 months	Likert Scale to assess image quality