Translational Development of Photon-counting CT Imaging
Study Details
Study Description
Brief Summary
Background:
Computed Tomography (CT) scans use x-rays to make three-dimensional images of the body. A new type of CT scanner, called a photon counting CT, measures the x-rays differently than a standard scanner. Researchers want to see if the new scanner can provide better images at a lower x-ray dose. They also want to compare the new images and technique to the standard CT scan images and techniques.
Objective:
To test a new type of CT scanner, called a photon counting CT, to see if it provides better images at a lower x-ray dose.
Eligibility:
People ages 18 and older who are scheduled for a CT scan as part of their standard care at the NIH Clinical Center
Design:
Participants will be screened with a collection and review of their medical records. Women of child bearing age will provide blood and urine samples.
Participants past imaging data and studies done after the photon counting CT scan may be collected, analyzed, and compared to the CT scans performed in this study.
Participants will have CT scans. During the test, they will lie on a padded table. The table will slide into a donut-shaped machine. An x-ray tube will move around the body, taking many pictures as it rotates.
Participants will be in the CT scan machine for about 20 minutes. The CT scans requested by the participant s healthcare team will be performed. One CT scan with the new technology will also be performed.
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| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
NIH develops new imaging techniques as one of its priorities for accelerating science, including methods for non-invasive patient assessments. Computed tomographic (CT) imaging is a mainstay of diagnostic imaging. The latest major technological advance is photon counting CT (PCCT) which uses a new x-ray detector that measures x-ray penetration of the body and the energy of each x-ray photon. NIH has one of three prototype Siemens PCCT CounT systems in the world for investigational use. The scanner can perform standard CT and PCCT imaging. In this protocol, NIH patients already enrolled in a clinical research protocol and who are referred to Radiology for diagnostic CT as part of that research may be enrolled in this study of PCCT. The diagnostic CT scan requested by their medical care team will be performed on the CounT scanner, providing the clinically indicated imaging, along with a single, brief PCCT exam to support PCCT development. The data will be used to characterize quality of the PCCT images and to develop testable hypotheses and new diagnostic applications using PCCT capabilities.
Current CT systems, such as the Siemens SOMATOM Flash, have two x-ray tubes, each paired with an x-ray detector that measures total x-ray penetration of the patient and uses that information to create the images. The CounT scanner is a modified version of the Flash in which one of the two standard detectors has been replaced with a PCCT detector. The two imaging modes for the CounT scanner are (i) standard detector study as in a Flash scanner and (ii) PCCT scan. The patient scan will thus include clinically indicated radiation exposure with the standard detector and research radiation with the PCCT detector. The CounT system is sited at the Clinical Center under a CRADA with Siemens Medical Solutions.
Compared to current scanners, PCCT offers four major advantages:
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lower radiation dose
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greater spatial resolution
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reduced imaging noise
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x-ray energy discrimination
The primary objectives are to:
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develop and characterize new medical imaging methods
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facilitate translation of PCCT advantages into clinically useful applications.
As a translational development protocol, all imaging studies are open-label and data may be analyzed as they are collected. Bias is minimized using objective measurements. Observational data may be characterized using descriptive statistics. Simple comparisons between the standard CT and PCCT may use paired and unpaired parametric and non-parametric techniques. These studies will form the foundation to develop advanced clinical imaging capabilities and applications.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Patients 750 male or female, 18 and older patients |
Device: PHOTON COUNTING CT
Enrolled patients will undergo the requested clinical diagnostic CT study on the PCCT system using the standard detector, with or without IV and/or oral contrast as indicated. They will also undergo a brief PCCT scan as part of the examination. The scan will thus include both clinically indicated radiation exposure with the standard detector and research radiation with the PCCT detector.
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Outcome Measures
Primary Outcome Measures
- Evaluate and confirm the clinical performance of PCCT [5 years]
To develop and characterize novel methods of evaluating patients using PCCT;
Secondary Outcome Measures
- Optimize and develop Clinical application advancement in CT Technology [5 years]
To facilitate the translation of PCCT technology and imaging methods into clinically useful applications for patients.
Eligibility Criteria
Criteria
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INCLUSION CRITERIA:
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NIH patients currently on an NIH research protocol who are referred to RAD&IS for CT examination as part of that research protocol
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18 years old or greater
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Able to understand and sign informed consent
EXCLUSION CRITERIA:
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Studies that specifically require dual source CT scan capability or where dual source CT scan is requested
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Studies ordered for an emergency indication
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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
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Lactating women who are unable to stop breast feeding for 24 hours following the administration of contrast
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Body weight >500 lbs (227 kg) or a body circumference that prevents the study subject from lying flat in the scanner
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Patients who have undergone PCCT examination within the past year.
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Any contraindications that the research team identifies from the subject, RAD&IS CT questionnaires, and/or History and Assessment
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Employees or staff supervised by the Principal Investigator or an Associate will not be recruited to participate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Institutes of Health Clinical Center | Bethesda | Maryland | United States | 20892 |
Sponsors and Collaborators
- National Institutes of Health Clinical Center (CC)
Investigators
- Principal Investigator: Elizabeth C Jones, M.D., National Institutes of Health Clinical Center (CC)
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- 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.
- 190070
- 19-CC-0070