CT Photon-Counting Clinical Trial
Official title:
Clinical Feasibility and Evaluation of Silicon Photon Counting CT
NCT number | NCT05838482 |
Other study ID # | 23000861577 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | September 7, 2023 |
Est. completion date | May 2025 |
The purpose of the study is to collect data to evaluate utility of the using photon-counting CT in a clinical setting.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | May 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Who are 18 years of age or older - Able to sign and date the informed consent form - Who have in the past 120 days or will in the future 30 days undergo a clinically-indicated CT exam of the head, neck, heart, chest, abdomen, pelvis, or extremities where images are available for this prior scheduled exam Exclusion Criteria: - Who are pregnant or lactating; - Who were previously enrolled in this study; - For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents - For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel; - Who need urgent or emergent care; - Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; OR - Who are unwilling to have GEHC personnel present for the CT exam. |
Country | Name | City | State |
---|---|---|---|
United States | Stanford University | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
GE Healthcare | Stanford University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Data Collection | Number of Participants with raw investigational photon-counting CT scan data along with prior standard of care diagnostic CT exam data/images | 1 year | |
Secondary | Image Quality | Reconstructed images produced from the raw investigational photon-counting CT scan will be scored for image quality using a Likert Scale (1 - Non-Diagnostic to 5 - Excellent Image Quality) | 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04781296 -
Spectral CT With Advanced CT Technology
|
N/A |