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Spectral Computed Tomography With Photon Counting Detector of Brain and Vessels.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03637907
Recruitment Status : Recruiting
First Posted : August 20, 2018
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Staffan Holmin, Karolinska Institutet

Study Description
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Brief Summary:
Primary purpose of the study is to show wether computed tomography with photon counting detector has a diagnostic image quality as good as, or better than classic computed tomography in investigations concerning stroke work-up.

Condition or disease Intervention/treatment
Tomography Stroke Other: Not applicable - no intervention.

Detailed Description:

Images of the skull/brain at the level of the inner ear/temporal bone and the level of nucleus lentiformis will be compared with the same patients routine brain done in TIA (transient ischemic attack)/stroke workup.

Images of the carotid plaque will be compared with the same patients routine CT-angiogram done in TIA/stroke workup.

Study Design
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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Spectral Computed Tomography With Photon Counting Detector of Brain and Vessels.
Actual Study Start Date : January 11, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

Groups and Cohorts
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Intervention Details:
  • Other: Not applicable - no intervention.
    No intervention is performed, just a CT with a new detector and comparison with the same patients older image.

Outcome Measures
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Primary Outcome Measures :
  1. Equal or better images vs classic computed tomography. [ Time Frame: During 2020 ]

    Are images taken with photon counting detector of brain and vessels worse, equal or better in comparison with ordinary computed tomography.

    Comparison of images with kernals (or algorithms) for bone and soft tissue at the level of the carotid plaque, inner ear/hindbrain and nucl lentiformis.

    Comparison of the ability of the spectral function - the ability to separate iodine, soft tissue and calcifications- if applicable.

    The comparison will be done as a grading (better, equal or worse) regarding the different kernals compared to routine CT exams from the same patient.

    Significance of difference between proportions with thh use of Fisher's exact test or Pearson's χ2 as appropriate. Evaluation with Cohen´s kappa with 95% CI to assess the level of inter-reader agreement



Secondary Outcome Measures :
  1. Diagnostic information in comparison with MRI [ Time Frame: During 2020 ]
    If MRI are performed of the patients brain and/or vessels - a comparison how the diagnostic information is/are relative images from MRI


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients in the ordinary stroke workup that do both CT brain and CTA of neck/brain vessel will be asked if we can ask them to participate in this study. Of the ones with carotid stenosis 30% or more we will ask patients to participate in this study.
Criteria

Inclusion Criteria:

  • Brain exam with CT and/or CT neck/brain vessels prior to this study. Regarding neck-vessel imaging - carotid stenosis of 30% or more. Normal kidney function.

Exclusion Criteria:

  • no contraindications to iodine contrast for neck-vessel imaging with contrast.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03637907


Contacts
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Contact: Staffan Holmin, Professor +46851777188 staffan.holmin@ki.se
Contact: Magnus Kaijser, Docent +46851770000 magnus.kaijser@ki.se

Locations
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Sweden
Karolinska Institutet, Karolinska University Hospital Recruiting
Stockholm, Sweden, 17176
Contact: Staffan Holmin, Professor    +46851770000    staffan.holmin@ki.se   
Sponsors and Collaborators
Karolinska Institutet
More Information
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Responsible Party: Staffan Holmin, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT03637907    
Other Study ID Numbers: KI-KTH-20180111
First Posted: August 20, 2018    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After the study is completed, contact the Principal Investigator for (anonymous) data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No