Liver CT Dose Reduction With Deep Learning Based Reconstruction

NCT ID: NCT05804799

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-12-31

Brief Summary

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A deep learning-based de-noising (DLD) reconstruction algorithm (ClariCT.AI) has the potential to reduce image noise and improve image quality. This capability of the CliriCT.AI program might enable dose reduction for contrast-enhanced liver CT examination. In this prospective multicenter study, whether the ClariCT.AI program can reduce the noise level of low-dose contrast-enhanced liver CT (LDCT) data and therefore, can provide comparable image quality to the standard dose of contrast-enhanced liver CT (SDCT) images will be evaluated.

The aim of this study is to compare image quality and diagnostic capability in detecting malignant tumors of LDCT with DLD to those of SDCT with MBIR using the predefined non-inferiority margin.

Detailed Description

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A deep learning-based de-noising (DLD) reconstruction algorithm (ClariCT.AI) has the potential to reduce image noise and improve image quality. This capability of the CliriCT.AI program might enable dose reduction for contrast-enhanced liver CT examination. In this prospective multicenter study, whether the ClariCT.AI program can reduce the noise level of low-dose contrast-enhanced liver CT (LDCT) data and therefore, can provide comparable image quality to the standard dose of contrast-enhanced liver CT (SDCT) images will be evaluated.

The aim of this study is to compare image quality and diagnostic capability in detecting malignant tumors of LDCT with DLD to those of SDCT with MBIR using the predefined non-inferiority margin.

Conditions

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Radiation Exposure Liver Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Liver CT study group

Patients with a suspicion of focal liver lesions had the plan to perform a contrast-enhanced liver CT scan.

The liver CT images were reconstructed by both low-dose scans with a deep-learning-based denoising program (ClariCT.AI) and standard-dose scans with model-based iterative reconstruction.

Contrast-enhanced liver CT scan

Intervention Type DIAGNOSTIC_TEST

The contrast-enhanced liver CT scans were obtained from all of the participants.

The liver CT images were reconstructed by both low-dose scans with a deep-learning-based denoising program (ClariCT.AI) and standard-dose scans with model-based iterative reconstruction.

Interventions

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Contrast-enhanced liver CT scan

The contrast-enhanced liver CT scans were obtained from all of the participants.

The liver CT images were reconstructed by both low-dose scans with a deep-learning-based denoising program (ClariCT.AI) and standard-dose scans with model-based iterative reconstruction.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Age between 20-year-old and 85 years old
* patients referred to the Radiology department to perform contrast-enhanced liver CT under the suspicion of focal liver lesions

Exclusion Criteria

* patients with estimated glomerular filtration rate \< 60 mL/min/1.73m2
* previous history of severe adverse reaction to iodinated contrast media.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, M.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Tubingen University Hospital

Tübingen, , Germany

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Korea University Guro Hospital

Seoul, , South Korea

Site Status

Countries

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Germany South Korea

References

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Lee DH, Lee JM, Lee CH, Afat S, Othman A. Image Quality and Diagnostic Performance of Low-Dose Liver CT with Deep Learning Reconstruction versus Standard-Dose CT. Radiol Artif Intell. 2024 Mar;6(2):e230192. doi: 10.1148/ryai.230192.

Reference Type DERIVED
PMID: 38231025 (View on PubMed)

Other Identifiers

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SNUH-2007-040-1139

Identifier Type: -

Identifier Source: org_study_id

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