CSPC-CT (Comparative Validation of GE PCCT)

Study overview

The study addresses a key clinical problem in coronary artery disease: conventional CT is useful and non-invasive, but it can be limited by image resolution, contrast resolution, blooming artefacts from calcium or stents, and radiation exposure. These limitations may reduce diagnostic confidence when assessing coronary stenosis, plaque burden, plaque composition, or in-stent restenosis. PCCT is expected to overcome some of these issues because it counts individual photons and provides higher spatial resolution, better tissue/material differentiation, improved image quality, and potentially lower radiation dose.

In practical terms, CSPC-CT will compare how well standard CT versus GE Photon Counting CT can identify and quantify coronary narrowing, characterize atherosclerotic plaques, distinguish calcified from non-calcified plaque components, and provide information that may influence clinical decision-making. This is especially relevant for high-risk patients, where better imaging could help clinicians decide whether invasive coronary angiography or revascularization is truly needed.

The study uses a paired-comparison design: high-risk patients act as their own controls by undergoing both imaging methods within 14 days. This design reduces variability between patients and allows a more rigorous comparison of diagnostic accuracy, plaque quantification, radiation dose, and potential impact on referral decisions for invasive procedures.

Overall, CSPC-CT aims to generate evidence on whether PCCT should be considered a superior non-invasive imaging tool for coronary evaluation. If PCCT demonstrates better diagnostic accuracy and plaque characterization than standard CT, the results could support improved risk stratification, more precise patient management, and better selection of patients who should proceed to invasive coronary procedures

Objectives

Primary objective:
To evaluate and compare the diagnostic accuracy of PCCT versus standard CT in detecting coronary stenosis, characterizing plaques, and determining the functional significance of coronary stenoses in patients with suspected coronary artery disease and in patients previously treated with coronary stents.

Secondary objectives:
To compare radiationexposure, assess the impact of image quality on diagnostic confidence, and determine whether PCCT providesadditional information on plaquecomposition and morphology.

Study design

The study is a prospective, observational, controlled, and open-label trial. Each patient undergoes both examinations: first standard cardiac CT/CCTA, followed by Photon Counting CT/CCTA, using a paired within-patient comparison design.

Operational structure:

• Screening/enrollment: Day -14 to Day 0, including informed consent, medical history, eligibility criteria, and laboratory tests.
• Visit 1 – Standard Cardiac CT: Day 0 to Day 7.
• Visit 2 – Photon Counting CT: within 14 days after Visit 1.
• Data analysis phase: after the last patient completes imaging, including image analysis, plaque quantification, SNR/CNR assessment, and radiomics.

The totalexpected study duration isapproximately 16 months, with recruitment of 300 patients over 6-8 months, targeting around 10-15 patients per week.