Clinical Evaluation of a Dual Energy CT System

N/ACompletedNCT02731937

GE Healthcare48 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

General CT Imaging

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 3 months

Secondary Outcomes

Image Quality assessment

Likert Scale to assess image quality

Time frame: 3 months