NCT04781296

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 18, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

April 19, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2022

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2025

Enrollment Period

1.7 years

First QC Date

February 18, 2021

Last Update Submit

November 26, 2025

Conditions

CT Photon-Counting

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Collect feedback on performance and images generated on the photon-counting CT.

    1 year

Study Arms (1)

Subject's Scanned with Investigational Device

EXPERIMENTAL
Device: CT with a photon-counting detector

Interventions

CT with a photon-counting detectorDEVICE

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.

Subject's Scanned with Investigational Device

Eligibility Criteria

Age50 Years+
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Iodine contrast is contraindicated.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital

Stockholm, 17164, Sweden

Location

Study Officials

  • Melissa Challman

    GE Healthcare

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2021

First Posted

March 4, 2021

Study Start

April 19, 2021

Primary Completion

December 14, 2022

Study Completion

December 14, 2022

Last Updated

December 4, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)