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

NCT03637907 | Unknown

• 1 other identifier: KI-KTH-20180111
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Tomography; Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diagnostic information in comparison with MRI

  During 2020

Interventions

Not applicable - no intervention. OTHER

No intervention is performed, just a CT with a new detector and comparison with the same patients older image.

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska Institutet, Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Staffan Holmin, Professor

CONTACT

+46851777188; staffan.holmin@ki.se

Magnus Kaijser, Docent

CONTACT

+46851770000; magnus.kaijser@ki.se

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: August 20, 2018
• Study Start: January 11, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 24, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)