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

• Conditions: Stroke; Tomography

• Registration Number: NCT03637907
• Lead Sponsor: Karolinska Institutet

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.

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 Timeline

• Study Start: 2018-01-11
• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-20
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-23
• Last Update Posted: 2021-02-24
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

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Exclusion Criteria

• no contraindications to iodine contrast for neck-vessel imaging with contrast.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Equal or better images vs classic computed tomography.	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

Name	Time	Method
Diagnostic information in comparison with MRI	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

Trial Locations

Locations (1)

Karolinska Institutet, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden