CT ImagesNCT05020262
Incisive CT Clinica Trial Protocol
An observational study of CT Images, run by Philips Healthcare (Suzhou) Co., Ltd..
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- CT Images
- What is being tested?
- CT Image reconstruction
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Sep 2021to Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Who may be able to join
- 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;
Who cannot join
- The investigator deemed it inappropriate to include the original image data for this clinical trial
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
- Conditions
- CT Images
- Being tested
- CT Image reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT Image reconstructionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Using PI/PC reconstruct raw data Receives: Other: CT Image reconstruction | |
| Control Group | Using Idose4/Cardiac Image reconstruct raw data Receives: Other: CT Image reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 2months
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: through study completion, an average of 2months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study startSep 2021 (estimated)
- Primary completionOct 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CT ImagesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Healthcare (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Second Hospital of Nanjing Medical University
- Responsible party
- Sponsor
- Investigators
- Chao Du, Deputy Director, Principal investigator, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020262
- Sponsor's protocol ID
- PD_CT_Incisive CT_2021_11264
- Status last verified
- Aug 2021
- First submitted
- 10 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Single-center, Readerblind, Nonrandomized Clinical Trial Was Conducted to Evaluate the Function of Incisive CT Precise Image and Precise Cardiac Function
- ClinicalTrials.gov ID
- NCT05020262
- Acronym / sponsor ID
- PD_CT_Incisive CT_2021_11264
- Conditions
- CT Images
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Philips Healthcare (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The Second Hospital of Nanjing Medical University
- Study start
- Sep 2021 (estimated)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | – | Other: CT Image reconstructionUsing PI/PC reconstruct raw data |
| Control Group | – | Other: CT Image reconstructionUsing Idose4/Cardiac Image reconstruct raw data |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (1 listed)
- The investigator deemed it inappropriate to include the original image data for this clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT Image reconstructionRetrospectively 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. | Other | Control Group, Test Group |
Primary outcome
The quality of PI/PC and iDose4/ cardiac imaging reconstructed images was basically equal or above 3 score
Time frame: 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
6 secondary outcomes
Imaging reconstruction enhancement condition using PI/PC compared with using iDose4/ cardiac basically equivalence to or above 3 score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: through study completion, an average of 2months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chao Du, Deputy Director principal investigator
The Second Hospital of Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of CT Images, run by Philips Healthcare (Suzhou) Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin Zhao (15000771460, Kevin.ZHAO_1@philips.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of PI/PC and iDose4/ cardiac imaging reconstructed images was basically equal or above 3 score (time frame: through study completion, an average of 2months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.