Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Cardiac CT allows the assessment of the heart and of the coronary arteries by use of ionising radiation. Although radiation exposure was significantly reduced in recent years, further decrease in radiation exposure is limited by increased image noise and deterioration in image quality. Recent evidence suggests that further technological refinements with artificial intelligence allows improved post-processing of images with reduction of image noise.
The present study aims at assessing the potential of a deep-learning image reconstruction algorithm in a clinical setting. Specifically, after a standard clinical scan, patients are scanned with lower radiation exposure and reconstructed with the DLIR algorithm. This interventional scan is then compared to the standard clinical scan.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal-dose versus Low-dose | Other | The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL. The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TrueFidelity | Device | TrueFidelity (Deep Learning Image Reconstruction, DLIR) software by GE Healthcare. The medical device in question is a novel reconstruction algorithm for raw CT data which is based on artificial intelligence approaches, namely deep-learning iterative reconstruction (DLIR). This DLIR algorithm will be installed on the console of the CT Revolution scanning device, which is in routine clinical use for cardiac CT scans at the Department of Nuclear Medicine at the University Hospital Zurich. Purpose of this installation is the assessment of the performance of the DLIR algorithm during a limited time span of six weeks. The algorithm will be CE-marked at the time of installation and use (statement by GE Healthcare provided separately). Its intended use is the reconstruction of CT datasets. Of note, the novel DLIR algorithm will not substitute any clinical routine procedures currently in use. That is, diagnosis will still be made using the standard reconstruction algorithms. |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Image Quality | Subjective image quality as measured by Likert scale from 1 (non-evaluable) to 5 (excellent) | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Signal Intensity | Signal intensity as average hounsfield units within a region of interest in the aortic root, change from experimental interventional to the control intervention | Day 1 |
| Image Noise |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ronny R Buechel, MD | Director of Cardiac Imaging | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital | Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27174030 | Background | Benz DC, Grani C, Hirt Moch B, Mikulicic F, Vontobel J, Fuchs TA, Stehli J, Clerc OF, Possner M, Pazhenkottil AP, Gaemperli O, Buechel RR, Kaufmann PA. Minimized Radiation and Contrast Agent Exposure for Coronary Computed Tomography Angiography: First Clinical Experience on a Latest Generation 256-slice Scanner. Acad Radiol. 2016 Aug;23(8):1008-14. doi: 10.1016/j.acra.2016.03.015. Epub 2016 May 9. | |
| 28200212 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment period: 08/May/2019 until 20/June/2019 Location: University Hospital Zurich, Department of Nuclear Medicine, Switzerland
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Normal-dose Versus Low-dose | The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL. The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Normal-dose Versus Low-dose | The standard intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL. The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Subjective Image Quality | Subjective image quality as measured by Likert scale from 1 (non-evaluable) to 5 (excellent) | Posted | Mean | Standard Deviation | Score on a Likert scale (0-5) 5=best | Day 1 |
|
1 day
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Low-dose | The experimental intervention is an additional CT scan with a lower dose (about 20 to 50% decrease) and a similar contrast agent administration that is reconstructed with a deep-learning image reconstruction immediately after the clinical CT scan. The additional time required is about 5 minutes. TrueFidelity: TrueFidelity (Deep Learning Image Reconstruction, DLIR) software by GE Healthcare. The medical device in question is a novel reconstruction algorithm for raw CT data which is based on artificial intelligence approaches, namely deep-learning iterative reconstruction (DLIR). This DLIR algorithm will be installed on the console of the CT Revolution scanning device, which is in routine clinical use for cardiac CT scans at the Department of Nuclear Medicine at the University Hospital Zurich. Purpose of this installation is the assessment of the performance of the DLIR algorithm during a limited time span of six weeks. The algorithm will be CE-marked at the time of installation and use (statement by GE Healthcare provided separately). Its intended use is the reconstruction of CT datasets. Of note, the novel DLIR algorithm will not substitute any clinical routine procedures currently in use. That is, diagnosis will still be made using the standard reconstruction algorithms. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ronny R. Buechel | University Hospital Zurich | +41442551059 | ronny.buechel@usz.ch |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 23, 2019 | Sep 28, 2021 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Image noise as standard deviation of hounsfield units within a region of interest in the aortic root, change from experimental interventional to the control intervention
| Day 1 |
| Signal-to-noise Ratio | Signal-to-noise ratio | Day 1 |
| Dose-length Products | Comparison of dose-length products | Day 1 |
| Plaque Volumes | Quantitative analysis of coronary artery plaque volumes | Day 1 |
| Background |
| Benz DC, Fuchs TA, Grani C, Studer Bruengger AA, Clerc OF, Mikulicic F, Messerli M, Stehli J, Possner M, Pazhenkottil AP, Gaemperli O, Kaufmann PA, Buechel RR. Head-to-head comparison of adaptive statistical and model-based iterative reconstruction algorithms for submillisievert coronary CT angiography. Eur Heart J Cardiovasc Imaging. 2018 Feb 1;19(2):193-198. doi: 10.1093/ehjci/jex008. |
| 30367497 | Background | Sahiner B, Pezeshk A, Hadjiiski LM, Wang X, Drukker K, Cha KH, Summers RM, Giger ML. Deep learning in medical imaging and radiation therapy. Med Phys. 2019 Jan;46(1):e1-e36. doi: 10.1002/mp.13264. Epub 2018 Nov 20. |
| 17936812 | Background | Toprak O. Conflicting and new risk factors for contrast induced nephropathy. J Urol. 2007 Dec;178(6):2277-83. doi: 10.1016/j.juro.2007.08.054. Epub 2007 Oct 22. |
| 28406318 | Background | Benz DC, Grani C, Hirt Moch B, Mikulicic F, Vontobel J, Fuchs TA, Stehli J, Clerc OF, Possner M, Pazhenkottil AP, Gaemperli O, Buechel RR, Kaufmann PA. A low-dose and an ultra-low-dose contrast agent protocol for coronary CT angiography in a clinical setting: quantitative and qualitative comparison to a standard dose protocol. Br J Radiol. 2017 Jun;90(1074):20160933. doi: 10.1259/bjr.20160933. Epub 2017 May 25. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Signal Intensity | Signal intensity as average hounsfield units within a region of interest in the aortic root, change from experimental interventional to the control intervention | Posted | Mean | Standard Deviation | Hounsfield units | Day 1 |
|
|
|
|
| Secondary | Image Noise | Image noise as standard deviation of hounsfield units within a region of interest in the aortic root, change from experimental interventional to the control intervention | Posted | Mean | Standard Deviation | Hounsfield units | Day 1 |
|
|
|
|
| Secondary | Signal-to-noise Ratio | Signal-to-noise ratio | Posted | Mean | Standard Deviation | Ratio | Day 1 |
|
|
|
|
| Secondary | Dose-length Products | Comparison of dose-length products | Posted | Median | Inter-Quartile Range | mGy*cm | Day 1 |
|
|
|
|
| Secondary | Plaque Volumes | Quantitative analysis of coronary artery plaque volumes | Posted | Mean | Standard Deviation | mm^3 | Day 1 |
|
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Normal-dose | The control intervention consists of the routinely performed cardiac CT datasets reconstructed with a standard iterative reconstruction algorithm (ASIR-V). Median radiation dose is about 0.5 mSv, range between about 0.2 and 1.2 mSv; median contrast agent administration about 45 mL, range between 35 and 55 mL. | 0 | 50 | 0 | 50 | 0 | 50 |
Not provided
Not provided
Not provided
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |