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Deep-Learning Image Reconstruction in CCTA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03980470
Recruitment Status : Recruiting
First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Information provided by (Responsible Party):
Ronny Buechel, University of Zurich

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: TrueFidelity Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Usefulness of Deep-Learning Image Reconstruction for Cardiac Computed Tomography Angiography - a Prospective, Non-randomized Observational Trial
Actual Study Start Date : May 3, 2019
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Device: 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.

No Intervention: 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.

Primary Outcome Measures :
  1. Subjective image quality as measured by Likert scale from 1 to 5, change from experimental interventional to the control intervention [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Signal-to-noise ratio and contrast-to-noise ratio, change from experimental interventional to the control intervention [ Time Frame: Day 1 ]
  4. Comparison of dose-length products and radiation exposure in mSv [ Time Frame: Day 1 ]
  5. Subjective analysis of plaque composition (calcified plaque, non-calcified plaque, mixed plaque) and lesion severity (below 50%, 50-70%, over 70%) [ Time Frame: Day 1 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03980470

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Contact: Valerie Treyer, PhD 00412551111

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University Hospital Recruiting
Zurich, Switzerland, 8091
Contact: Valerie Treyer, PhD   
Contact: Ronny R Buechel, MD    +41 44 255 10 59   
Principal Investigator: Ronny R Buechel, MD         
Sponsors and Collaborators
University of Zurich
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Principal Investigator: Ronny R Buechel, MD Director of Cardiac Imaging

Publications of Results:

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Responsible Party: Ronny Buechel, PD Dr. med. Ronny R. Buechel, University of Zurich Identifier: NCT03980470    
Other Study ID Numbers: USZ-2019-00533
First Posted: June 10, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases