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Spectral CT With Advanced CT Technology

Sponsor
GE Healthcare (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04781296
Collaborator
Prismatic Sensors AB (Other)
30
Enrollment
1
Location
1
Arm
22.4
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: CT with a photon-counting detector
 N/A

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
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
Spectral Computed Tomography With Photon-counting Detector
Actual Study Start Date :
Apr 19, 2021
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Evaluate feasibility of the photon-counting CT in a clinical setting. [1 year]

    The primary objective of this study is to collect and evaluate raw CT scan data collected using the photon-counting CT.

Secondary Outcome Measures

  1. Collect feedback on performance and images generated on the photon-counting CT. [1 year]

    Gather feedback on the performance and image quality of the reconstructed images produced by using the photon-counting CT.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
Male
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Karolinska University Hospital Stockholm Sweden 17164

Sponsors and Collaborators

  • GE Healthcare
  • Prismatic Sensors AB

Investigators

  • Study Director: Brian Thomsen, GE Healthcare

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT04781296
Other Study ID Numbers:
  • 20201218-01
First Posted:
Mar 4, 2021
Last Update Posted:
May 23, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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

Study Results

No Results Posted as of May 23, 2022