CT Photon-CountingNCT05838482
Clinical Feasibility and Evaluation of Silicon Photon Counting CT
An observational study of CT Photon-Counting, run by GE Healthcare at 1 site in United States.
Trial summary
The purpose of the study is to collect data to evaluate utility of the using photon-counting CT in a clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- CT Photon-Counting
- What is being tested?
- CT Photon-Counting
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2023to 30 Apr 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subject population will consist of adults that are 18-years of age or older, and who have undergone a prior clinically-indicated CT exam of at least one of the following anatomical area(s): head, neck, heart, chest, abdomen, pelvis, and/or extremities.
Who may be able to join
- Who are 18 years of age or older
- Able to sign and date the informed consent form
- Who have in the past 120 days or will in the future 30 days undergo a clinically-indicated CT exam of the head, neck, heart, chest, abdomen, pelvis, or extremities where images are available for this prior scheduled exam
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 need urgent or emergent care;
- 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; OR
- Who are unwilling to have GEHC personnel present for the CT exam.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to collect data to evaluate utility of the using photon-counting CT in a clinical setting.
Read the detailed description
Data collected in this study includes an assessment of image quality parameters including spatial resolution, image contrast, and noise that will evaluate the product and how this photon-counting CT technology can be used to reduce the overall radiation dose in CT imaging, and enhance clinical applications for CT technology. This data and analysis will help support regulatory submission.
- Conditions
- CT Photon-Counting
- Being tested
- CT Photon-Counting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Photon-CountingDevice
Enrolled subjects will complete an exam using the photon-counting CT, with or without IV contract as indicated. Images will then be compared with the previously acquired CT conducted as standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Subject's Scanned with Investigational Device | Eligible and consented subjects will be scanned using the investigational Pluto Photon-Counting CT system. Receives: Device: CT Photon-Counting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data Collection
Number of Participants with raw investigational photon-counting CT scan data along with prior standard of care diagnostic CT exam data/images
Measured: 1 year
Secondary outcomes (1)
Image Quality
Reconstructed images produced from the raw investigational photon-counting CT scan will be scored for image quality using a Likert Scale (1 - Non-Diagnostic to 5 - Excellent Image Quality)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start7 Sep 2023
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CT Photon-CountingStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Responsible party
- Sponsor
- Investigators
- Brian Thomsen, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838482
- Sponsor's protocol ID
- 23000861577
- Status last verified
- Jun 2026
- First submitted
- 18 Apr 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Scan data will be shared with other researchers but all will be completely deidentified.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility and Evaluation of Silicon Photon Counting CT
- ClinicalTrials.gov ID
- NCT05838482
- Acronym / sponsor ID
- 23000861577
- Conditions
- CT Photon-Counting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 1 May 2023 (actual)
- 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 purpose of the study is to collect data to evaluate utility of the using photon-counting CT in a clinical setting.
Detailed description
Data collected in this study includes an assessment of image quality parameters including spatial resolution, image contrast, and noise that will evaluate the product and how this photon-counting CT technology can be used to reduce the overall radiation dose in CT imaging, and enhance clinical applications for CT technology. This data and analysis will help support regulatory submission.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subject's Scanned with Investigational Device | – | Device: CT Photon-CountingEligible and consented subjects will be scanned using the investigational Pluto Photon-Counting CT system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population will consist of adults that are 18-years of age or older, and who have undergone a prior clinically-indicated CT exam of at least one of the following anatomical area(s): head, neck, heart, chest, abdomen, pelvis, and/or extremities.
Key inclusion criteria (3 listed)
- Who are 18 years of age or older
- Able to sign and date the informed consent form
- Who have in the past 120 days or will in the future 30 days undergo a clinically-indicated CT exam of the head, neck, heart, chest, abdomen, pelvis, or extremities where images are available for this prior scheduled exam
Key exclusion criteria (7 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 need 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 |
|---|---|---|
| CT Photon-CountingEnrolled subjects will complete an exam using the photon-counting CT, with or without IV contract as indicated. Images will then be compared with the previously acquired CT conducted as standard of care. | Device | Subject's Scanned with Investigational Device |
Primary outcome
Data Collection
Time frame: 1 year
Number of Participants with raw investigational photon-counting CT scan data along with prior standard of care diagnostic CT exam data/images
1 secondary outcome
Image Quality
Time frame: 1 year
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 17 Jun 2026.
- Individual participant dataSharing planned: Undecided. Scan data will be shared with other researchers but all will be completely deidentified.
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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.
Brian Thomsen study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CT Photon-Counting, run by GE Healthcare at 1 site in United States.
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 7 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 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Data Collection (time frame: 1 year). 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 17 Jun 2026.