Clinical Evaluation of a Dual Energy CT System

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.

Study Overview

• Status: Completed
• Conditions: General CT Imaging
• Intervention / Treatment: Device: GE Healthcare Revolution CT Scanner (CT Scanner)

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: GE Healthcare CT Revolution (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.	Device: GE Healthcare Revolution CT Scanner (CT Scanner); Raw CT Scan Data; Other Names: CT scanner

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Principal Investigator: Ali Islam, MD, St. Joseph's Helathcare

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: March 24, 2016
• First Submitted That Met QC Criteria: April 6, 2016
• First Posted (Estimate): April 8, 2016

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 106-2015-GES-0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes