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

NCT06691659 | Recruiting

• 1 other identifier: 856690
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Radiation Protection; Image Enhancement

Outcome Measures

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.

  24 months

Interventions

CT-DACE DIAGNOSTIC_TEST

Photon Counting CT scan

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Canon Medical Systems, USA: collaborator

Study Sites (1)

University of Pennsylvania - Center for Advanced Computed Tomography Imaging Services (CACTIS)

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Study Officials

• Peter B Noel, PhD

  UPENN Radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Schubert

CONTACT

215-573-6569; erin.schubert@pennmedicine.upenn.edu

Hannah Straughn

CONTACT

443-739-4971; hannah.straughn@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 15, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)