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CompletedNCT02731937Updated May 8, 2017

Clinical Evaluation of a Dual Energy CT System

An interventional study of GE Healthcare Revolution CT Scanner (CT Scanner) in General CT Imaging, sponsored by GE Healthcare. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-08.

Sponsored by GE Healthcare · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was Jul 2016, 10 years 3 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • General CT Imaging
03

In context

Lead sponsor

GE Healthcare is the lead sponsor of 176 studies on the registry; 21 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.

Browse GE Healthcare studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
48 participants (actual)

Study arms

  • 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)

Interventions

  • DeviceGE Healthcare Revolution CT Scanner (CT Scanner)

    Raw CT Scan Data

    Also known as: CT scanner

06

What researchers measure

Primary outcomes

  1. 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

  1. Image Quality assessment

    Likert Scale to assess image quality

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2016, a primary completion of Jul 2016 and a completion of Jul 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 24, 2016
First posted
Apr 8, 2016
Start
Apr 2016
Primary completionActual
Jul 2016
CompletionActual
Jul 2016
Last update
May 8, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02731937
Lead sponsor
GE Healthcare
Responsible party
Sponsor
First posted
Apr 8, 2016
Start date
Apr 2016
Primary completion
Jul 2016
Completion
Jul 2016
Last update
May 8, 2017

Study contacts

Ali Islam, MD
principal investigator · St. Joseph's Helathcare

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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