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

• Sponsor: Karolinska Institutet (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03637907
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Anticipated Duration (Months): 47.6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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	Phase
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

• Study Type: Observational
• Anticipated 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: Jan 11, 2018
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Dec 31, 2021

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Karolinska Institutet, Karolinska University Hospital	Stockholm		Sweden	17176

Sponsors and Collaborators

• Karolinska Institutet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Staffan Holmin, Professor, Karolinska Institutet
• ClinicalTrials.gov Identifier: NCT03637907
• Other Study ID Numbers: KI-KTH-20180111
• First Posted: Aug 20, 2018
• Last Update Posted: Feb 24, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 24, 2021