Clinical Evaluation of a Dual Energy CT System

NCT ID: NCT02731937

Last Updated: 2017-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2016-07-31

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.

Conditions

General CT Imaging

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

GE Healthcare Revolution CT Scanner (CT Scanner)

Intervention Type: DEVICE

Raw CT Scan Data

Interventions

GE Healthcare Revolution CT Scanner (CT Scanner)

Raw CT Scan Data

Intervention Type: DEVICE

Other Intervention Names

CT scanner

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali Islam, MD

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Helathcare

Other Identifiers

106-2015-GES-0005

Identifier Type: -

Identifier Source: org_study_id