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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03637907
• Other study ID #: KI-KTH-20180111
• Status: Recruiting
• Start date: January 11, 2018
• Est. completion date: December 31, 2021

Study information

• Verified date: February 2021
• Source: Karolinska Institutet
• Contact: Staffan Holmin, Professor
• Phone: +46851777188
• Email: staffan.holmin[@]ki.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stroke
• Tomography

Intervention

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

Locations

Country	Name	City	State
Sweden	Karolinska Institutet, Karolinska University Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Equal or better images vs classic computed tomography.	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 ?2 as appropriate. Evaluation with Cohen´s kappa with 95% CI to assess the level of inter-reader agreement	During 2020
Secondary	Diagnostic information in comparison with MRI	If MRI are performed of the patients brain and/or vessels - a comparison how the diagnostic information is/are relative images from MRI	During 2020