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Clinical Trials/NCT04781296
NCT04781296CompletedNot Applicable

Spectral Computed Tomography With Photon-counting Detector

GE Healthcare2 sites in 1 country30 target enrollmentStarted: April 19, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
2
Primary Endpoint
Evaluate feasibility of the photon-counting CT in a clinical setting.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
50 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Age >50 years
  • •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.

Arms & Interventions

Subject's Scanned with Investigational Device

Experimental

Intervention: CT with a photon-counting detector (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Collect feedback on performance and images generated on the photon-counting CT.(1 year)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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