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Spectral CT With Advanced CT Technology

Spectral Computed Tomography With Photon-counting Detector

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04781296
Enrollment
30
Registered
2021-03-04
Start date
2021-04-19
Completion date
2022-12-14
Last updated
2025-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CT Photon-Counting

Brief summary

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.

Interventions

DEVICECT with a photon-counting detector

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.

Sponsors

Prismatic Sensors AB
CollaboratorUNKNOWN
GE Healthcare
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Iodine contrast is contraindicated.

Design outcomes

Primary

MeasureTime frameDescription
Evaluate feasibility of the photon-counting CT in a clinical setting.1 yearThe primary objective of this study is to collect and evaluate raw CT scan data collected using the photon-counting CT.

Secondary

MeasureTime frameDescription
Collect feedback on performance and images generated on the photon-counting CT.1 yearGather feedback on the performance and image quality of the reconstructed images produced by using the photon-counting CT.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026