Spectral CT With Advanced CT Technology

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.

Study Overview

• Status: Completed
• Conditions: CT Photon-Counting
• Intervention / Treatment: Device: CT with a photon-counting detector

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 Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden, 17164
    • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subject's Scanned with Investigational Device	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: Prismatic Sensors AB
• Investigators: Study Director: Melissa Challman, GE Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2021
• Primary Completion (Actual): December 14, 2022
• Study Completion (Actual): December 14, 2022

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: March 1, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20201218-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No