Translational Development of Photon-counting CT Imaging
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- 750
Summary
- Conditions
- Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Device Feasibility
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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: lower radiation dose greater spatial resolution reduced imaging noise x-ray energy discrimination The primary objectives are to: develop and characterize new medical imaging methods 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.
Tracking Information
- NCT #
- NCT03878134
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Elizabeth C Jones, M.D. National Institutes of Health Clinical Center (CC)