Incisive CT Clinica Trial Protocol

• Conditions: CT Images
• Interventions: Other: CT Image reconstruction

• Registration Number: NCT05020262
• Lead Sponsor: Philips Healthcare (Suzhou) Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-10
• Study First Submitted QC: 2021-08-18
• Last Update Submitted: 2021-08-18
• Study First Posted: 2021-08-25
• Last Update Posted: 2021-08-25
• Study Start: 2021-09
• Primary Completion: 2021-10
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control Group	CT Image reconstruction	Using Idose4/Cardiac Image reconstruct raw data
Test Group	CT Image reconstruction	Using PI/PC reconstruct raw data

Primary Outcome Measures

Name	Time	Method
The quality of PI/PC and iDose4/ cardiac imaging reconstructed images was basically equal or above 3 score	through study completion, an average of 2months	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

Secondary Outcome Measures

Name	Time	Method
Imaging reconstruction clarity using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score	through study completion, an average of 2months	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
Imaging reconstruction Noise level using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score	through study completion, an average of 2months	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
Imaging reconstruction enhancement condition using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score	through study completion, an average of 2months	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
Imaging reconstruction diagnostic confidence using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score	through study completion, an average of 2months	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
Imaging reconstruction Image texture using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score	through study completion, an average of 2months	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
Imaging reconstruction Image artifacts using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score	through study completion, an average of 2months	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