Computed Tomography
Conditions
Brief summary
The purpose of the study is to collect data to evaluate utility of a next generation spectral CT system in a clinical setting.
Detailed description
Data collected in this study includes an assessment of image quality parameters to evaluate the product. This data and analysis will help support regulatory submissions.
Interventions
DEVICEResearch CT
Participants will undergo a research CT on an investigational Spectral CT Imaging scanner which will be matched to their prior or scheduled SOC CT. Scans will be matched on anatomy, radiation dose, and contrast administration.
Sponsors
GE Healthcare
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Who are ≥18 years of age; * Able to sign and date the informed consent form; AND, * Who have in the past 90 days or will in the future 30 days of the investigational scan undergo a clinically indicated CT exam within the St. Luke's University Hospital Network of the neck, chest, abdomen, pelvis, or extremities.
Exclusion criteria
* Who are pregnant or lactating; * Who were previously enrolled in this study; * For planned contrast-enhanced investigational CT exams, anyone with known or suspected allergy to iodinated contrast agents; * For planned contrast-enhanced investigational 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluable Raw Research Scans | Through study completion, an average of 1 year | Number of participants who research scan is deemed evaluable (i.e., no issues with participant motion or contrast administration/timing) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment | Through study completion, an average of 1 year | Number of Adverse Events and/or Serious Adverse Events reported. |
Countries
United States
Contacts
CONTACTMelissa Challman, MPH, CCRP
STUDY_DIRECTORBrian Thomsen
GE Healthcare
Outcome results
None listed