Incisive CT Clinica Trial Protocol

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: CT Images
• Intervention / Treatment: Other: CT Image reconstruction

• Study Type: Observational
• Enrollment (Anticipated): 112

Contacts and Locations

• Study Contact: Name: Kevin Zhao; Phone Number: 15000771460; Email: Kevin.ZHAO_1@philips.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The original data of the images are from the patient base in the age range of 18 to 75 years (18≤ age ≤75 years)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Test Group; Using PI/PC reconstruct raw data	Other: CT Image reconstruction; 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.
Control Group; Using Idose4/Cardiac Image reconstruct raw data	Other: CT Image reconstruction; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Philips Healthcare (Suzhou) Co., Ltd.
• Collaborators: The Second Hospital of Nanjing Medical University
• Investigators: Principal Investigator: Chao Du, Deputy Director, The Second Hospital of Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2021
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 18, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 18, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: PD_CT_Incisive CT_2021_11264

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No