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Deep-Learning Image Reconstruction in CCTA

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
TrueFidelity
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients referred for cardiac CT angiography
  • Age ≥ 18 years
  • Written informed consent

Exclusion Criteria:

  • Pregnancy or breast-feeding
  • Enrollment of the investigator, his/her family members, employees and other dependent persons
  • Renal insufficiency (GFR below 35 mL/min/1.73 m²)

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Normal-dose versus Low-dose

Arm Description

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.

Outcomes

Primary Outcome Measures

Subjective Image Quality
Subjective image quality as measured by Likert scale from 1 (non-evaluable) to 5 (excellent)

Secondary Outcome Measures

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
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
Signal-to-noise Ratio
Signal-to-noise ratio
Dose-length Products
Comparison of dose-length products
Plaque Volumes
Quantitative analysis of coronary artery plaque volumes

Full Information

First Posted
May 24, 2019
Last Updated
October 26, 2021
Sponsor
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT03980470
Brief Title
Deep-Learning Image Reconstruction in CCTA
Official Title
Usefulness of Deep-Learning Image Reconstruction for Cardiac Computed Tomography Angiography - a Prospective, Non-randomized Observational Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 8, 2019 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
June 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal-dose versus Low-dose
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TrueFidelity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective Image Quality
Description
Subjective image quality as measured by Likert scale from 1 (non-evaluable) to 5 (excellent)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Signal Intensity
Description
Signal intensity as average hounsfield units within a region of interest in the aortic root, change from experimental interventional to the control intervention
Time Frame
Day 1
Title
Image Noise
Description
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
Time Frame
Day 1
Title
Signal-to-noise Ratio
Description
Signal-to-noise ratio
Time Frame
Day 1
Title
Dose-length Products
Description
Comparison of dose-length products
Time Frame
Day 1
Title
Plaque Volumes
Description
Quantitative analysis of coronary artery plaque volumes
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients referred for cardiac CT angiography Age ≥ 18 years Written informed consent Exclusion Criteria: Pregnancy or breast-feeding Enrollment of the investigator, his/her family members, employees and other dependent persons Renal insufficiency (GFR below 35 mL/min/1.73 m²)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronny R Buechel, MD
Organizational Affiliation
Director of Cardiac Imaging
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27174030
Citation
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.
Results Reference
background
PubMed Identifier
28200212
Citation
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.
Results Reference
background
PubMed Identifier
30367497
Citation
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.
Results Reference
background
PubMed Identifier
17936812
Citation
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.
Results Reference
background
PubMed Identifier
28406318
Citation
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.
Results Reference
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Deep-Learning Image Reconstruction in CCTA

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