- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07242690
PET-CT Imaging With PCD-CT
Advancing PET-CT Imaging With Photon Counting Detector CT
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Charleston, South Carolina, United States, 29407
- Medical University of South Carolina
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years
- Scheduled for or completed standard-of-care PET-CT of head and neck within ≤30 days
Exclusion Criteria:
- Non-diagnostic PET-CT
- Intervening therapy between scans
- Iodinated contrast allergy
- Renal insufficiency (GFR < 45)
- Pregnancy
- Gross motion artifacts
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: PET CT scan
To compare the image quality of PET images constructed using non-contrast PCD-CT image data to PET images constructed using conventional standard-of-care non-contrast EID-CT image data by performing a quantitative analysis of measurable image quality parameters.
|
A direct qualitative comparison of the subjective PET image quality will be performed. Two blinded board-certified radiologists/nuclear medicine physicians will independently review PET images constructed using non-contrast PCD-CT data as well as PET images constructed using standard of care non-contrast EID-CT data in random order. Both raters will assess PET images subjectively regarding overall image quality using a five-point Likert scale. The rating will be defined as: (1) non-diagnostic - insufficient diagnostic confidence, (2) poor - low diagnostic confidence, (3) moderate - average diagnostic confidence; (4) good - high diagnostic confidence, and (5) excellent - full diagnostic confidence. |
|
Other: PCD-CT
To compare the subjective image quality of PET images constructed using non-contrast PCD-CT image data to PET images constructed using conventional standard-of-care non-contrast EID-CT image data by performing a qualitative analysis of diagnostic confidence as determined by board-certified radiologists/nuclear medicine physicians during image review.
|
To compare the subjective image quality of PET images constructed using non-contrast PCD-CT image data to PET images constructed using conventional standard-of-care non-contrast EID-CT image data by performing a qualitative analysis of diagnostic confidence as determined by board-certified radiologists/nuclear medicine physicians during image review.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
improve PET image w/ non-contrast PCD-CT data
Time Frame: 2 years
|
We expect that the subjective PET image quality will be improved by using non-contrast PCD-CT data for construction resulting in higher diagnostic confidence; demonstrating a case for the integration of PCD-CT into standard of care clinical PET-CT imaging in the future.
There will be no direct benefit to study participants and the outcome will not be directly reported to the treatment team or patient and will not impact treatment or care received.
|
2 years
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Kevin Horn, PhD, MD, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00146888
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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