General CT ImagingNCT02731937
Clinical Evaluation of a Dual Energy CT System
A study testing GE Healthcare Revolution CT Scanner (CT Scanner) in people with General CT Imaging, run by GE Healthcare.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- General CT Imaging
- What is being tested?
- GE Healthcare Revolution CT Scanner (CT Scanner)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Who are 18 year of age or older;
- Able to sign and date the informed consent form; AND
- Who have in the past year undergone a clinically-indicated CT exam of the head, neck, chest, abdomen, pelvis, or extremities
Who cannot join
- Who are pregnant or lactating;
- Who were previously enrolled in this study;
- For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents;
- For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
- Who are in need of urgent or emergent care;
- Diabetic patients on metformin (Glucophage)
- 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
- Who are unwilling to have GEHC personnel present for the CT exam
About this study
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
- Being tested
- GE Healthcare Revolution CT Scanner (CT Scanner)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GE Healthcare Revolution CT Scanner (CT Scanner)Device
Also called CT scanner
Raw CT Scan Data
| Study group | Role | What they receive |
|---|---|---|
| GE Healthcare CT Revolution (CT scanner) | Other | 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. Receives: Device: GE Healthcare Revolution CT Scanner (CT Scanner) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
Image Quality assessment
Likert Scale to assess image quality
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General CT ImagingStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ali Islam, MD, Principal investigator, St. Joseph's Helathcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731937
- Sponsor's protocol ID
- 106-2015-GES-0005
- Status last verified
- May 2017
- First submitted
- 24 Mar 2016
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Dual Energy CT System
- ClinicalTrials.gov ID
- NCT02731937
- Acronym / sponsor ID
- 106-2015-GES-0005
- Conditions
- General CT Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GE Healthcare CT Revolution (CT scanner) | Other | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Who are 18 year of age or older;
- Able to sign and date the informed consent form; AND
- Who have in the past year undergone a clinically-indicated CT exam of the head, neck, chest, abdomen, pelvis, or extremities
Key exclusion criteria (8 listed)
- Who are pregnant or lactating;
- Who were previously enrolled in this study;
- For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents;
- For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
- Who are in need of urgent or emergent care;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GE Healthcare Revolution CT Scanner (CT Scanner)Also: CT scannerRaw CT Scan Data | Device | GE Healthcare CT Revolution (CT scanner) |
Primary outcome
Raw CT Scan Data
Time frame: 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.
1 secondary outcome
Image Quality assessment
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Islam, MD principal investigator
St. Joseph's Helathcare
Questions about this trial
What is this clinical trial studying?
A study testing GE Healthcare Revolution CT Scanner (CT Scanner) in people with General CT Imaging, run by GE Healthcare.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Raw CT Scan Data (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.