Next-Generation Photon-Counting CT Technology: Development and Clinical Evaluation (CT-DACE)

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.

Study Overview

• Status: Recruiting
• Conditions: Image Enhancement; Radiation Protection
• Intervention / Treatment: Diagnostic test: CT-DACE

Detailed Description

This protocol aims to assess the diagnostic benefits of a next-generation Photon-Counting Computed Tomography (PCCT) system in patients undergoing routine CT imaging.

Recruitment will be conducted among patients scheduled for CT scans (with or without contrast agent) 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.

Analyses will be conducted as needed, based on the specific validation or quantitative measures required for each clinical CT scan. This study will involve three radiologists for each cohort, selected based on their training in the specific anatomical region of interest, analyzing images from PCCT scanning. They will interpret both conventional CT slices and the additional spectral and high-resolution data provided by the PCCT. The images will be reviewed on a state-of-the-art workstation with a high-resolution monitor. Performance metrics will be set individually for each anatomical region.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Erin Schubert; Phone Number: 215-573-6569; Email: Erin.schubert@pennmedicine.upenn.edu
• Study Contact Backup: Name: Hannah Straughn; Phone Number: 443-739-4971; Email: hannah.straughn@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania - Center for Advanced Computed Tomography Imaging Services (CACTIS)
      • Contact: Erin Schubert; Phone Number: 215-573-6569
      • Contact: Hannah Straughn; Phone Number: 443-739-4971
      • Principal Investigator: Peter Noel, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Canon Medical Systems, USA
• Investigators: Principal Investigator: Peter B Noel, PhD, UPENN Radiology

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Estimated): October 14, 2025
• Last Update Submitted That Met QC Criteria: October 9, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 856690

Drug and device information, study documents

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