Diagnostic ImagingNCT06281808
Photon Counting Detector CT Image Quality
A study testing Photon Counting Detector CT in people with Diagnostic Imaging and Tomography, X Ray Computed, run by Reto Sutter, MD at 1 site in Switzerland.
Trial summary
This study aims to compare subjective image quality and diagnostic accuracy of a photon counting detector computed tomography (PCD-CT) scanner compared with an energy integrating detector (EID)-CT scanner as the reference standard. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diagnostic Imaging, Tomography, X Ray Computed
- What is being tested?
- Photon Counting Detector CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient admitted for non-contrast enhanced CT scan of the upper or lower extremity at the radiology department of Balgrist University Hospital
- Signed general consent ("Information zur Weiterverwendung gesundheitsbezogener Daten und Proben zu Forschungszwecken")
- >18 years of age
- Written consent to participate in this study
Who cannot join
- Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Women: pregnancy
- Age below 18 years
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to consent and/or follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
- Enrolment of the PI, his/her family members, employees and other dependent persons
- Body mass above 200 kg.
- Body mass below 31 kg.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Balgrist University Hospital
Zurich, Canton of Zurich, 8008
About this study
Official title: Image Quality and Diagnostic Accuracy of Photon Counting Computed Tomography of the Upper and Lower Extremity
This study aims to compare subjective image quality and diagnostic accuracy of a photon counting detector computed tomography (PCD-CT) scanner compared with an energy integrating detector (EID)-CT scanner as the reference standard.
Read the detailed description
Computed tomography (CT) imaging plays a key role in diagnostic radiology, and is particularly valuable in assessing a myriad of musculoskeletal conditions (e.g. trauma, degenerative disorders, post-surgical follow-up, inflammatory diseases).
The vast majority of today's CT scanners are equipped with an energy-integrating detector (EID), which converts energy of incoming X-ray photons in a two-step process into electric signals: First, scintillators generate visible light, which in turn is converted to the electric signal by photodiodes.
Recently, photon-counting detector computed tomography (PCD-CT) scanners became commercially available and have been introduced to improve imaging performance through direct transformation of X-ray photons into electron hole pairs upon absorption in a semiconductor layer, generating an electrical signal proportional to the photon energy.
Current literature has shown that PCD-CT can offer higher spatial resolution, increased contrast-to-noise ratio, higher dose-efficiency, and inherent multi-spectral imaging capacity.
Moreover, the results from cadaver studies suggest that PCD-CT can preserve image quality with reduced radiation dose.
However, data on the diagnostic accuracy of PCD-CT compared to EID-CT is currently limited in the field of musculoskeletal radiology.
In addition to conventional CT acquisition, multi-spectral CT imaging in patients with gout and after trauma, is used in clinical routine to delineate materials with a specific absorption coefficient: in gout, urate crystals can be visualized, while after trauma, bone marrow edema can be detected. For EID-CT, different techniques for multi-spectral CT imaging are available (e.g. fast kV switching, dual source CT) which are widely used in clinical routine. Multi-spectral imaging is also inherently available for recently introduced PCD-CT. However, data on diagnostic accuracy of multi-spectral PCD-CT is currently lacking.
- Conditions
- Diagnostic Imaging, Tomography, X Ray Computed
- Being tested
- Photon Counting Detector CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon Counting Detector CTDevice
Photon counting detector CT scan with dose arbitrarily reduced compared to EID CT scan (e.g., half the dose of EID CT)
| Study group | Role | What they receive |
|---|---|---|
| Photon Counting Detector CT | Experimental | PCD CT Receives: Device: Photon Counting Detector CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Quality PCD CT
Likert scale based - 5 point Likert scale (0 = worst, 5 = best)
Visual gradings of PCD-CT image quality. Image quality will be assessed by teams of experienced musculoskeletal radiologists. Images from consistent sets of intra-subject PCD-CT and EID-CT data will be presented to derive the primary outcome data, in particular using visual analog scales (Likert-Scales). Inter-reader reliability will be assessed.
Measured: 2 years
Diagnostic Accuracy PCD CT
This will involve the calculation of sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy. The EID-CT image interpretation of the attending radiologists, as documented in the written report, will serve as reference standard against which the performance of PCD-CT will be compared. In cases with inconclusive written reports and image findings of EID-CT, a review committee consisting of experienced radiologists (e.g., other attending radiologists, chief of radiology) will be convened, and consensus reading including clinical correlation by consulting with the treating physicians and specialists involved in the patient's care will be done. Diagnostic confidence will be additionally analyzed for PCD-CT scans on a Likert-Scale. Inter-reader reliability will be assessed.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start28 Jan 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic ImagingStudies of the same condition, open and under way.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reto Sutter, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reto Sutter, MD, Balgrist University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06281808
- Sponsor's protocol ID
- R490
- Status last verified
- Oct 2025
- First submitted
- 5 Feb 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Quality and Diagnostic Accuracy of Photon Counting Computed Tomography of the Upper and Lower Extremity
- ClinicalTrials.gov ID
- NCT06281808
- Acronym / sponsor ID
- R490
- Conditions
- Diagnostic Imaging, Tomography, X Ray Computed
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Reto Sutter, MDUniversity, hospital or other
- Study start
- 28 Jan 2024 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Feb 2024 (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.
This study aims to compare subjective image quality and diagnostic accuracy of a photon counting detector computed tomography (PCD-CT) scanner compared with an energy integrating detector (EID)-CT scanner as the reference standard.
Detailed description
Computed tomography (CT) imaging plays a key role in diagnostic radiology, and is particularly valuable in assessing a myriad of musculoskeletal conditions (e.g. trauma, degenerative disorders, post-surgical follow-up, inflammatory diseases).
The vast majority of today's CT scanners are equipped with an energy-integrating detector (EID), which converts energy of incoming X-ray photons in a two-step process into electric signals: First, scintillators generate visible light, which in turn is converted to the electric signal by photodiodes.
Recently, photon-counting detector computed tomography (PCD-CT) scanners became commercially available and have been introduced to improve imaging performance through direct transformation of X-ray photons into electron hole pairs upon absorption in a semiconductor layer, generating an electrical signal proportional to the photon energy.
Current literature has shown that PCD-CT can offer higher spatial resolution, increased contrast-to-noise ratio, higher dose-efficiency, and inherent multi-spectral imaging capacity.
Moreover, the results from cadaver studies suggest that PCD-CT can preserve image quality with reduced radiation dose.
However, data on the diagnostic accuracy of PCD-CT compared to EID-CT is currently limited in the field of musculoskeletal radiology.
In addition to conventional CT acquisition, multi-spectral CT imaging in patients with gout and after trauma, is used in clinical routine to delineate materials with a specific absorption coefficient: in gout, urate crystals can be visualized, while after trauma, bone marrow edema can be detected. For EID-CT, different techniques for multi-spectral CT imaging are available (e.g. fast kV switching, dual source CT) which are widely used in clinical routine. Multi-spectral imaging is also inherently available for recently introduced PCD-CT. However, data on diagnostic accuracy of multi-spectral PCD-CT is currently lacking.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Photon Counting Detector CT | Experimental | Device: Photon Counting Detector CTPCD CT |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient admitted for non-contrast enhanced CT scan of the upper or lower extremity at the radiology department of Balgrist University Hospital
- Signed general consent ("Information zur Weiterverwendung gesundheitsbezogener Daten und Proben zu Forschungszwecken")
- >18 years of age
- Written consent to participate in this study
Key exclusion criteria (8 listed)
- Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.)
- Women: pregnancy
- Age below 18 years
- Known or suspected non-compliance, drug or alcohol abuse
- Inability to consent and/or follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject
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 |
|---|---|---|
| Photon Counting Detector CTPhoton counting detector CT scan with dose arbitrarily reduced compared to EID CT scan (e.g., half the dose of EID CT) | Device | Photon Counting Detector CT |
Primary outcome
Image Quality PCD CT
Time frame: 2 years
Likert scale based - 5 point Likert scale (0 = worst, 5 = best) Visual gradings of PCD-CT image quality. Image quality will be assessed by teams of experienced musculoskeletal radiologists. Images from consistent sets of intra-subject PCD-CT and EID-CT data will be presented to derive the primary outcome data, in particular using visual analog scales (Likert-Scales). Inter-reader reliability will be assessed.
Diagnostic Accuracy PCD CT
Time frame: 2 years
This will involve the calculation of sensitivity, specificity, positive predictive value, negative predictive value, and overall accuracy. The EID-CT image interpretation of the attending radiologists, as documented in the written report, will serve as reference standard against which the performance of PCD-CT will be compared. In cases with inconclusive written reports and image findings of EID-CT, a review committee consisting of experienced radiologists (e.g., other attending radiologists, chief of radiology) will be convened, and consensus reading including clinical correlation by consulting with the treating physicians and specialists involved in the patient's care will be done. Diagnostic confidence will be additionally analyzed for PCD-CT scans on a Likert-Scale. Inter-reader reliability will be assessed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photon Counting Detector CT in people with Diagnostic Imaging and Tomography, X Ray Computed, run by Reto Sutter, MD at 1 site in Switzerland.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Image Quality PCD CT (time frame: 2 years). The study lists 2 primary outcomes in all. 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 2 Oct 2025.