Translational Development of Photon-counting CT Imaging

Translational Development of Photon-Counting CT Imaging

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.

Study Overview

• Status: Completed
• Conditions: Vascular Diseases; Cancer; Metabolic Bone Disease; Inflammatory Disease
• Intervention / Treatment: Device: PHOTON COUNTING CT Scanner

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 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:

• lower radiation dose
• greater spatial resolution
• reduced imaging noise
• x-ray energy discrimination

As a translational development protocol, all imaging studies are open-label and data may be analyzed as they are collected.

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients undergoing conventional and Photon Counting CT scan on the investigational scanner; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimize and develop Clinical application advancement in CT Technology	To facilitate the translation of PCCT technology and imaging methods into clinically useful applications for patients.	5 years

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)
• Investigators: Principal Investigator: Elizabeth C Jones, M.D., National Institutes of Health Clinical Center (CC)

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2019
• Primary Completion (Actual): January 18, 2022
• Study Completion (Actual): January 18, 2022

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 31, 2023
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Computed Tomography; Photon Counting CT; Photon Counting Detectors
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Metabolic Diseases; Musculoskeletal Diseases; Vascular Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: 190070; 19-CC-0070

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No