Incisive CT Clinica Trial Protocol

Study Overview
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Brief Summary
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The purpose of this study was to evaluate whether the new features of Incisive CT: Precise Image, (PI) and Precise Cardiac (PC) had the expected effectiveness

Official Title
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A Retrospective, Single-center, Readerblind, Nonrandomized Clinical Trial Was Conducted to Evaluate the Function of Incisive CT Precise Image and Precise Cardiac Function

Conditions
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CT Images

Intervention / Treatment
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* Other: CT Image reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The original data of the images are from the patient base in the age range of 18 to 75 years (18≤ age ≤75 years) Original image data are collected in Incisive CT (version 4.5) and traceable; Time range for inclusion of original image data: from the start of the clinical trial to the completion of collection in compliance with this protocol; Exclusion Criteria: - The investigator deemed it inappropriate to include the original image data for this clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Test Group<br>Using PI/PC reconstruct raw data | Other: CT Image reconstruction<br>* Retrospectively collects CT Images and reconstruct using PI/PC and Idose4/Cardiac Images to assessment the performance of the two new software functions of Incisive CT. No direct intervention to patients. And ICF is exempted by EC.<br>|
| Control Group<br>Using Idose4/Cardiac Image reconstruct raw data | Other: CT Image reconstruction<br>* Retrospectively collects CT Images and reconstruct using PI/PC and Idose4/Cardiac Images to assessment the performance of the two new software functions of Incisive CT. No direct intervention to patients. And ICF is exempted by EC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The quality of PI/PC and iDose4/ cardiac imaging reconstructed images was basically equal or above 3 score | Scoring criteria 5 points The image quality of PI/PC is better than that of iDose4/ cardiac imaging, which can be used for diagnosis, very satisfied 4 points The image quality of PI/PC is better than that of contrast products, and the image of iDose4/ cardiac imaging can be used for diagnosis, satisfactory 3 points The image quality of PI/PC is basically equivalent to that of iDose4/ cardiac imaging. The image quality is defective, which does not affect the diagnosis, but is normal 2. The image quality of PI/PC is not lower than iDose4/ cardiac imaging, but the image quality is poor, which affects the diagnosis and is not satisfactory 1 points The image quality is lower than iDose4/ cardiac imaging after using PI/PC, the image quality is poor, cannot diagnose, unsatisfactory | through study completion, an average of 2months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Imaging reconstruction enhancement condition using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score | Score enhancement 5 points - Very satisfied very clear and good, can be used for diagnosis 4 points - Satisfaction is clear and good and can be used for diagnosis 3 points - Generally defective, acceptable, without affecting diagnosis 2 points - Unsatisfactory enhancement is poor, affecting diagnosis 1 point - Unsatisfactory enhancement is poor and cannot be diagnosed | through study completion, an average of 2months | 
| Imaging reconstruction diagnostic confidence using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score | Score diagnostic confidence 5 points - Very satisfied the lesion or tissue structure is shown very clearly and can be used for diagnosis Score 4 - Satisfied that the lesion or tissue structure is clearly displayed and can be used for diagnosis 3 points - Generally the lesion or tissue structure is shown with acceptable clarity and does not affect the diagnosis 2 points - unsatisfactory lesion or tissue structure showing poorly, affecting diagnosis 1 point - Unsatisfactory lesion or tissue structure is not clearly displayed and cannot be diagnosed | through study completion, an average of 2months | 
| Imaging reconstruction clarity using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score | Score clarity 5 points - Very satisfied with the clear edge, the details show very clear and clear and can be used for diagnosis 4 points - Satisfied with a clear edge, showing clear and clear details that can be used for diagnosis 3 points - General clarity acceptable without prejudice to diagnosis 2 points - Undersatisfied edges and details show smooth, unclear, affecting diagnosis 1 point - Unsatisfied edges and detail display that is too smooth and unclear to affect diagnosis | through study completion, an average of 2months | 
| Imaging reconstruction Noise level using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score | Score noise level 5 points - Very satisfied with very low or no noise, can be used for diagnosis 4 points - Satisfied with low or mild noise, can be used for diagnosis 3 points - General The noise value is normal, acceptable and does not affect the diagnosis 2 points - unsatisfactory high noise, affecting diagnosis 1 point - Dissatisfaction with high noise and excessive noise that affects diagnosis | through study completion, an average of 2months | 
| Imaging reconstruction Image texture using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score | Score image texture 5 points - Very satisfied with texture very clear, intuitive feel similar to high dose scan image quality, can be used for diagnosis 4 points - Satisfied with clear texture and good image quality for diagnostic purposes 3 points - General texture is normal, image edges or some areas of speckled blur or smoothness, but acceptable, does not affect the diagnosis Score 2 - An undersatisfied image has acceptable speckled blurring that will not be misdiagnosed as lesions and affect the diagnosis 1 point - Unsatisfactory image texture and poor texture, blotchy, affecting diagnosis | through study completion, an average of 2months | 
| Imaging reconstruction Image artifacts using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score | Score image artifacts 5 points - Very satisfied no artifacts, can be used for diagnosis 4 points - Satisfied with few artifacts, can be used for diagnosis 3 points - Generally acceptable artifacts that do not affect diagnosis 2 points - undersatisfaction has some artifacts that affect diagnosis 1 point - Unsatisfied with severe artifacts that affect diagnosis | through study completion, an average of 2months |