NCT05171764

Dual Energy Cardiac CT Data Collection and Evaluation

Feasibility and Data Collection of Dual Energy Cardiac CT on a Wide Coverage System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study is intended to collect clinical feasibility data using this prototype research mode for the purposes of understanding potential clinical impact, potential limitations and strengths, and to further develop the technique through development of image reconstruction and processing approaches or identification of other areas of development required.

Detailed description

Up to 38 subjects may be enrolled to achieve the target number of 30 evaluable subjects. Withdrawn or discontinued subjects who are enrolled and received the investigational scan, may be replaced. Subject participation will be deemed complete once the diagnostic and investigational scans are completed. A subject is considered evaluable when images and raw data from the diagnostic single energy cardiac CT scan and raw data from the investigational dual energy cardiac CT scan have been collected successfully and demonstrate a diagnostic interpretation.

Conditions

• Cardiovascular Diseases

Interventions

Type	Name	Description
DEVICE	Additional Gemstone Spectral Imaging (GSI) cardiac scan	After the subject undergoes the clinically prescribed cardiac Computed Tomography (CT) scan for their diagnostic purposes, the investigational Gemstone Spectral Imaging (GSI) scan will be conducted following the diagnostic CT scan utilizing the same contrast administration.

Timeline

• Start date: 2022-11-14
• Primary completion: 2023-10-13
• Completion: 2023-10-13
• First posted: 2021-12-29
• Last updated: 2023-12-18

Locations

1 site across 1 country: Switzerland

Regulatory

• FDA-regulated device study