CT Photon-CountingNCT04781296
Spectral CT With Advanced CT Technology
A study testing CT with a photon-counting detector in people with CT Photon-Counting, run by GE Healthcare at 1 site in Sweden.
Trial summary
The purpose of the study is to collect data to evaluate feasibility of the using photon-counting CT in a clinical setting. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- CT Photon-Counting
- What is being tested?
- CT with a photon-counting detector
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 19 Apr 2021to 14 Dec 2022
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >50 years
- Male
- Normal renal function per standardized guidelines (GFR > 60 mL/min)
- Previous CT examination at KS no more than 12 months prior to the study examination
- Signed informed consent
Who cannot join
- Iodine contrast is contraindicated.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Spectral Computed Tomography With Photon-counting Detector
The purpose of the study is to collect data to evaluate feasibility 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.
- Conditions
- CT Photon-Counting
- Being tested
- CT with a photon-counting detector
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT with a photon-counting detectorDevice
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 | Experimental | Not described Receives: Device: CT with a photon-counting detector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate feasibility of the photon-counting CT in a clinical setting.
The primary objective of this study is to collect and evaluate raw CT scan data collected using the photon-counting CT.
Measured: 1 year
Secondary outcomes (1)
Collect feedback on performance and images generated on the photon-counting CT.
Gather feedback on the performance and image quality of the reconstructed images produced by using the photon-counting CT.
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 posted4 Mar 2021
- Study start19 Apr 2021
- Primary completion14 Dec 2022
- Study completion14 Dec 2022
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The single group model will enroll subjects from 5 anatomical areas (lungs, brain/carotid vessels, heart/chest, MSK and abdomen) where CT imaging is applicable and where data on the photon-counting CT is needed to assess feasibility and guide further development of the technology.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Prismatic Sensors AB
- Responsible party
- Sponsor
- Investigators
- Melissa Challman, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04781296
- Sponsor's protocol ID
- 20201218-01
- Status last verified
- Nov 2025
- First submitted
- 18 Feb 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectral Computed Tomography With Photon-counting Detector
- ClinicalTrials.gov ID
- NCT04781296
- Acronym / sponsor ID
- 20201218-01
- Conditions
- CT Photon-Counting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- Prismatic Sensors AB
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 14 Dec 2022 (actual)
- Study completion
- 14 Dec 2022 (actual)
- First posted
- 4 Mar 2021 (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 feasibility 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The single group model will enroll subjects from 5 anatomical areas (lungs, brain/carotid vessels, heart/chest, MSK and abdomen) where CT imaging is applicable and where data on the photon-counting CT is needed to assess feasibility and guide further development of the technology.
| Arm | Type | Receives |
|---|---|---|
| Subject's Scanned with Investigational Device | Experimental | Device: CT with a photon-counting detector |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >50 years
- Male
- Normal renal function per standardized guidelines (GFR > 60 mL/min)
- Previous CT examination at KS no more than 12 months prior to the study examination
- Signed informed consent
Key exclusion criteria (1 listed)
- Iodine contrast is contraindicated.
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 with a photon-counting detectorEnrolled 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
Evaluate feasibility of the photon-counting CT in a clinical setting.
Time frame: 1 year
The primary objective of this study is to collect and evaluate raw CT scan data collected using the photon-counting CT.
1 secondary outcome
Collect feedback on performance and images generated on the photon-counting CT.
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 4 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for CT Photon-Counting
RecruitingObservational study
Photon-counting CT Scan vs Standard HRCT Scan in the Identification of Idiopathic Pulmonary Fibrosis
IPF, ILD
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.
Melissa Challman 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?
A study testing CT with a photon-counting detector in people with CT Photon-Counting, run by GE Healthcare at 1 site in Sweden.
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 5 inclusion and 1 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 4 Dec 2025. 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 Sweden. 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?
Evaluate feasibility of the photon-counting CT in a clinical setting. (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 4 Dec 2025; AzTrials last refreshed its copy on 27 Oct 2026.