Evaluating a new CT imaging system
Clinical Feasibility and Evaluation of Silicon Photon Counting CT
GE Healthcare · NCT06769594
This study is testing a new CT imaging system to see if it provides better picture quality for doctors to use in treating patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | GE Healthcare (industry) |
| Locations | 1 site (Madison, Wisconsin) |
| Trial ID | NCT06769594 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on the utility of a next generation CT system in a clinical setting. It involves assessing various image quality parameters such as spatial resolution, image contrast, and noise. The data gathered will support regulatory submissions and help determine the effectiveness of the new imaging technology.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for a clinically indicated imaging exam within a specified timeframe.
Not a fit: Patients who are pregnant, lactating, or have known allergies to iodinated contrast agents may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved imaging quality and diagnostic capabilities for patients undergoing CT scans.
How similar studies have performed: Other studies evaluating advanced imaging technologies have shown promise, indicating potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects may be included in this study if they meet the following criteria: 1. Who are 18 year of age or older; 2. Able to sign and date the informed consent form; AND 3. Who have in the past 120 days or will in the future 30 days from the day of consent undergo a clinically indicated imaging exam (MRI, CT, radiograph, nuclear medicine, ultrasound, bone material density, interventional radiology procedure) of the head, neck, heart, chest, abdomen, pelvis, or extremities where images are available for this prior exam. Exclusion Criteria: Subjects may be excluded from participating in study if they meet any of the following criteria: 1. Who are pregnant or lactating; 2. Who were 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. Who are in need of urgent or emergent care; 6. 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; and, 7. Who are unwilling to have GEHC personnel present for the CT exam.
Where this trial is running
Madison, Wisconsin
- University of Wisconsin, Madison — Madison, Wisconsin, United States (RECRUITING)
Study contacts
- Study coordinator: Melissa Challman, MPH, CCRP
- Email: melissa.challman@gehealthcare.com
- Phone: 858-221-3007
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Computed Tomography