Next-Generation Photon-Counting CT Technology: Development and Clinical Evaluation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-89
SponsorUniversity of Pennsylvania
About this trial
This project aims to develop and evaluate a next-generation photon-counting CT prototype, and assess whether next-generation photon-counting CT--which enables reduced radiation dose, high spatial resolution, and spectral imaging--would facilitate improved diagnostic performance for abdominal, cardiothoracic, musculoskeletal, and neuroimaging.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 to 89.
Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
Not pregnant (based on attestation)
Disqualifiers
Pregnant women will not be included. All females of childbearing potential must attest that they are not pregnant before CT imaging.
Participants with a known contrast allergy.
Any current medical condition, illness, or disorder, as assessed by medical record review and/or self-reported, that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.
Trial population
Recruited patients are scheduled to undergo a routine CT scan (with or without contrast) at the Perelman Center for Advanced Medicine. Patients in the study will undergo abdominal, cardiovascular, chest, musculoskeletal, and neuroimaging scans. The design involves 50 participants per body region to gather preliminary data and assess diagnostic benefits for future research and clinical translation. This a total of 250 patients for the initial study.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
CT-DACE
Diagnostic testPhoton Counting CT scan
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Primary Outcome Measure
In this clinical study evaluating a photon-counting computed tomography (CT) scanner, the Primary Outcome Measures include image quality assessed by signal-to-noise ratio, contrast-to-noise ratio, and resolution via edge response function, as well as diagnostic accuracy determined by radiologist interpretation compared to gold-standard diagnostic methods when available from previous scans. For each body region, image data will be subjectively evaluated for image quality using a Likert scale assessing overall image quality, presence of artifacts, and diagnostic adequacy for the specific clinical indication.
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Pennsylvania
Lead sponsor
Canon Medical Systems, USA
Collaborator
Source ClinicalTrials.gov