An interventional study of PHOTON COUNTING CT Scanner in Cancer, Inflammatory Disease and Vascular Diseases, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-01.
Sponsored by National Institutes of Health Clinical Center (CC) · Not applicable, Interventional, and Diagnostic
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.
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 Clinical Center will use a prototype Siemens PCCT CounT systems built for clinical 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 abbreviated PCCT exam of an organ or body part to support PCCT feasibility of the PCCT to provide better images in several small groups of patients with selected medical conditions. 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 over a limited field with the PCCT detector. The CounT system is sited at the Clinical Center under a CRADA (Cooperative research and development agreement) with Siemens Medical Solutions.
Compared to current scanners, PCCT is expected to offer four major advantages:
As a translational development protocol, all imaging studies are open-label and data may be analyzed as they are collected.
261 studies on the registry are indexed under Bone Diseases; 49 are open to participants now.
This study's enrollment of 67 is above the median of 54 across 148 interventional studies indexed under Bone Diseases.
Browse Bone Diseases studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 367 studies on the registry; 27 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.
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EXCLUSION CRITERIA:
18 and older patients who undergo the conventional CT scan and the photon counting CT (PCCT) scan. Patient's images on the conventional scanner provide internal control to compare to the PCCT images.
Device: PHOTON COUNTING CT Scanner
Enrolled patients will undergo the requested clinical diagnostic CT study on the investigational system using the standard detector, with or without IV and/or oral contrast as indicated and an limited scan of one body region using the PCCT detector. Both scans are able to be performed on the same scanner during the same examination.
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.
Time frame: 2 years and 3 months, 27 months
Patients referred for diagnostic CT scan with clinical history or at risk status for conditions such as urologic cancers, lung cancers, as well as patients with conditions such as inflammatory lung or soft tissue diseases, arterial disorders of small vessels, or metabolic bone disease.
| Milestone | Patients Enrolled to Receive the Intervention PCCT CT Scan |
|---|---|
| Started | 67 |
| Completed | 56 |
| Not completed | 11 |
| Withdrew: Scanner downtime or scheduling conflict | 11 |
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.
| score on a scale | Patients Enrolled in Protocol |
|---|---|
| Mean Difference in Diagnostic Image Quality Grading of Photon Counting CT vs Conventional CT Images. | 0.947368421 ± 0.478877133 |
Collected over 24 hours unanticipated events related to the device are apparent at the time of scanning. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Patients Receiving the Intervention PCCT CT Scan | 0/56 (0%) | 0/56 (0%) | 0/56 (0%) |
11 patients could not be scanned on the PCCT investigational scanner after being enrolled due to scanner downtime.
| Age, Continuous(years) | Patients Referred for Diagnostic CT Scans |
|---|---|
| Mean | 52 ± 14.5 |
| Sex: Female, Male(Participants) | Patients Referred for Diagnostic CT Scans |
|---|---|
| Female | 39 |
| Male | 28 |
| Ethnicity (NIH/OMB)(Participants) | Patients Referred for Diagnostic CT Scans |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 64 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Patients Referred for Diagnostic CT Scans |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 6 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 52 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
| Adults referred for diagnostic CT scan(Participants) | Patients Referred for Diagnostic CT Scans |
|---|---|
| Count of participants | 67 |
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National Institutes of Health Clinical Center (CC)