Spectral CT With Advanced CT Technology

CT Photon-Counting Clinical Trial

Official title:

Spectral Computed Tomography With Photon-counting Detector

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04781296
• Other study ID #: 20201218-01
• Status: Completed
• Phase: N/A
• Start date: April 19, 2021
• Est. completion date: December 14, 2022

Study information

• Verified date: June 2023
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to collect data to evaluate feasibility of the using photon-counting CT in a clinical setting.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CT Photon-Counting

Intervention

Device:
• CT 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.

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
GE Healthcare	Prismatic Sensors AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Secondary	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.	1 year