Cancer Clinical Trial
Official title:
Translational Development of Photon-Counting CT Imaging
Verified date | January 2022 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Using an investigational CT scanner which uses a new type of detector to capture X-rays, (a photon counting CT detector), the goal of this experimental study is to compare conventional CT images to CT images using the photon counting detector in patients undergoing CT scans for clinically indicated reasons. The main question it aims to answer is whether the images produced using the new detectors are superior in quality. Participants will undergo the clinically indicated CT images and the photon counting detector CT images of a limited area during the same examination time.
Status | Completed |
Enrollment | 67 |
Est. completion date | January 18, 2022 |
Est. primary completion date | January 18, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | - INCLUSION CRITERIA: - NIH patients currently on an NIH research protocol who are referred to RAD&IS for CT examination as part of that research protocol - 18 years old or greater - Able to understand and sign informed consent EXCLUSION CRITERIA: - Studies that specifically require simultaneous dual source CT scan capability or where dual source CT scan is requested - Studies ordered for an emergency indication - Pregnant women. Subjects of child-bearing potential will undergo serum or urine pregnancy testing within 72 hours before examination. Post-menopausal and surgically sterilized subjects are automatically exempt from this testing - Lactating women who are unable to stop breast feeding for 24 hours following the administration of contrast - Body weight >500 lbs (227 kg) or a body circumference that prevents the study subject from lying flat in the scanner - Patients who have undergone PCCT examination within the past year. - Any contraindications that the research team identifies from the subject, RAD&IS CT questionnaires, and/or History and Assessment - Employees or staff supervised by the Principal Investigator or an Associate will not be recruited to participate |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institutes of Health Clinical Center (CC) |
United States,
Pourmorteza A, Symons R, Henning A, Ulzheimer S, Bluemke DA. Dose Efficiency of Quarter-Millimeter Photon-Counting Computed Tomography: First-in-Human Results. Invest Radiol. 2018 Jun;53(6):365-372. doi: 10.1097/RLI.0000000000000463. — View Citation
Pourmorteza A, Symons R, Reich DS, Bagheri M, Cork TE, Kappler S, Ulzheimer S, Bluemke DA. Photon-Counting CT of the Brain: In Vivo Human Results and Image-Quality Assessment. AJNR Am J Neuroradiol. 2017 Dec;38(12):2257-2263. doi: 10.3174/ajnr.A5402. Epub 2017 Oct 5. — View Citation
Symons R, Pourmorteza A, Sandfort V, Ahlman MA, Cropper T, Mallek M, Kappler S, Ulzheimer S, Mahesh M, Jones EC, Malayeri AA, Folio LR, Bluemke DA. Feasibility of Dose-reduced Chest CT with Photon-counting Detectors: Initial Results in Humans. Radiology. 2017 Dec;285(3):980-989. doi: 10.1148/radiol.2017162587. Epub 2017 Jul 28. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Difference in Diagnostic Image Quality Grading of Photon Counting CT vs Conventional CT Images. | Mean difference in relative image quality grading of CT images using Photon counting detectors vs. conventional detectors in group of patients with various clinical conditions. Scale name "Visual grading analysis (VGA)" . Expert radiologist observers compare the relative grades of the images from the PCCT to the grades of the same patient's reference images from conventional CT acquired at the same time. The visual grading scale incorporates technical factors in the acquisition and image display (such as contrast, noise and presence of artifacts and post processing). Grading is based on 5 point scale. 1- lowest image quality, 5- highest image quality. 5 is a better result. Scale as follows: 1 Images not usable- severe limitations for diagnostic use, 2 Limited -some loss of information, significant limitations for clinical use, 3 Adequate -moderate limitations for diagnostic use, 4 Good-minimal limitations for clinical use, 5 Excellent- no limitations for clinical diagnosis. | 2 years and 3 months, 27 months |
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