CT Photon Counting
Conditions
Brief summary
The purpose of the study is to evaluate the investigational Edge-on Silicon Photon Counting CT device in a clinical setting.
Detailed description
Images from prior standard of care diagnostic CT exams for these subjects will also be collected. Data collected in this study will be used for technology development, scientific evaluation, marketing and education, and regulatory submissions for future products. This is a pre-market, prospective, open-label, non-randomized, single arm data collection clinical study conducted at one site in Sweden.
Interventions
DEVICEInvestigational Edge-on Silicon Photon Counting CT device
Administration of IV contrast material, if applicable, shall be done according to the hospital's SOC. Administration of oral contrast material, if applicable, shall also be done according to the hospital's SOC. Images will then be compared with the previously acquired CT conducted as standard of care. The investigational scan will take approximately 60-120 minutes.
Sponsors
GE Healthcare
Karolinska University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 25 years of age or older; 2. Able to sign and date the informed consent form; AND 3. Have undergone a clinically indicated CT exam of the head, neck, chest, abdomen, pelvis, or extremities where images are available within 90 days of investigational scanning.
Exclusion criteria
1. Pregnant or lactating; 2. Previously enrolled in this study; 3. For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents; 4. For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel; 5. Need urgent or emergent care; 6. 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 7. Are unwilling to have GEHC personnel present for the CT exam.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Data Collection | 12 months | Raw investigational CT scan data along with standard of care raw CT scan data/images |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Information | 12 months | Type and number of AEs and SAEs |
| Image Quality | 12 months | Images created from the raw investigational CT scan data will be scored for image quality using a Likert Scale (1 - Non-Diagnostic to 5 - Excellent Image Quality) |
Countries
Sweden
Contacts
STUDY_DIRECTORBrian W Thomsen
GE Healthcare
Outcome results
None listed