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

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.

Study Overview

• Status: Unknown
• Conditions: Stroke; Tomography
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 10

Contacts and Locations

• Study Contact: Name: Staffan Holmin, Professor; Phone Number: +46851777188; Email: staffan.holmin@ki.se
• Study Contact Backup: Name: Magnus Kaijser, Docent; Phone Number: +46851770000; Email: magnus.kaijser@ki.se

Study Locations

• Sweden
  • Stockholm, Sweden, 17176
    • Recruiting
    • Karolinska Institutet, Karolinska University Hospital
    • Contact: Staffan Holmin, Professor; Phone Number: +46851770000; Email: staffan.holmin@ki.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 χ2 as appropriate. Evaluation with Cohen´s kappa with 95% CI to assess the level of inter-reader agreement	During 2020

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Karolinska Institutet

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2018
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: March 16, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: KI-KTH-20180111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the study is completed, contact the Principal Investigator for (anonymous) data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No