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Liver CT Dose Reduction With Deep Learning Based Reconstruction

Comparison of Image Quality and Diagnostic Pefromance of Low Dose Liver CT With Deep Learning Reconstuction to Standard Dose CT: A Prospective Multicenter Non-inferiority Trial

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05804799
Enrollment
300
Registered
2023-04-07
Start date
2021-01-01
Completion date
2022-12-31
Last updated
2023-04-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer, Radiation Exposure

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTContrast-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.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 85 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Measurement of standard deviation of CT attenuation values at the liverwithin 6 months from acquisition of liver CT scansStandard deviation of CT attenuation values at the liver parenchyma

Secondary

MeasureTime frameDescription
Sensitivity to detect malignant liver tumorwithin 6 months from acquisition of liver CT scansSensitivity of liver CT scans to detect malignant liver tumor

Countries

Germany, South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026