NCT06691659

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: —

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.

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.

Conditions

• Radiation Protection
• Image Enhancement

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	CT-DACE	Photon Counting CT scan

Timeline

• Start date: 2024-11-19
• Primary completion: 2026-11-30
• Completion: 2026-11-30
• First posted: 2024-11-15
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States