NCT05804799

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
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: —

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.

Conditions

• Radiation Exposure
• Liver Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-08-31
• Completion: 2022-12-31
• First posted: 2023-04-07
• Last updated: 2023-04-12

Locations

3 sites across 2 countries: Germany, South Korea

Regulatory

• FDA-regulated device study