Next-generation spectral CT imaging data collection from clinical scans

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects imaging data from adults undergoing a clinically indicated CT exam within the St. Luke’s network, focusing on image quality and spectral CT parameters. The goal is to characterize performance of a next-generation spectral CT system in a real-world clinical setting. Data and analyses will inform regulatory submissions and potential future use of the technology. Participation requires consent and follows standard safety and inclusion criteria related to CT imaging and contrast use. GE Healthcare leads the project with no external collaborators and location-specific procedures at the Bethlehem, PA site.

Why it matters

Who can join: the full rules

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.

Where it's running

• St Luke's University Health Network
  Bethlehem, Pennsylvania, United States Recruiting

Study contacts

• Study coordinator: Melissa Challman, MPH, CCRP
• Email: melissa.challman@gehealthcare.com
• Phone: 18582213007

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.