An observational study in Radiation Exposure and Liver Cancer, sponsored by Seoul National University Hospital. Completed at 3 sites in 2 countries. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-04-12.
Sponsored by Seoul National University Hospital · Observational
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.
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.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's enrollment of 300 is above the median of 200 across 350 observational studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with a suspicion of focal liver lesions had the plan to do a contrast-enhanced liver CT scan.
Exclusion Criteria:
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.
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.
Measurement of standard deviation of CT attenuation values at the liver
Standard deviation of CT attenuation values at the liver parenchyma
Time frame: within 6 months from acquisition of liver CT scans
Sensitivity to detect malignant liver tumor
Sensitivity of liver CT scans to detect malignant liver tumor
Time frame: within 6 months from acquisition of liver CT scans
Plan to share: No
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This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital