Low Contrast Agent and Radiation Dose Protocol for Liver CT in Patients With HCC

Study Overview
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Brief Summary
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The purpose of this study is to investigate the image quality and clinical feasibility of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.

Detailed Description
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The purpose of this study is to investigate the image quality (CNR, subjective inage quality, vessel and lesion conspicuity) and clinical feasibility (rate of lesion detection) of double low-dose liver computed tomography using a deep-learning-based iodine contrast boosting algorithm in participants at high risk for hepatocellular carcinoma.

Official Title
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Low Contrast Agent and Radiation Dose Protocol Liver CT With Deep-learning-based Contrast Boosting Model in Patients at High Risk for HCC: Prospective, Randomized, Single Blinded - Preliminary Study

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Radiation: Low radiation dose CT
* Radiation: Conventional CT (radiation)
* Drug: Low contrast dose CT
* Drug: Conventional CT (contrast agent)
* Other: Deep-learning based contrast boosting algorithms


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Liver cirrhosis Tumor marker (aFP, PIVKA) elevation Nodular lesion on USG Received RFA for HCC Exclusion Criteria: hypersensitivity at iodine GFR under 30 BMI over 30 Nursing or pregnant women enrolled the other study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional liver CT<br>Underwent conventional liver CT on HCC high-risk patient | Radiation: Conventional CT (radiation)<br>* Underwent liver CT without change of radiation.<br>Drug: Conventional CT (contrast agent)<br>* Underwent liver CT without change of contrast media doses.<br>* Other names: Standard contrast medium dosage;|
| Experimental: Double low dose CT<br>Underwent double low dose liver CT with 30% lower radiation dose and 20% contrast media on HCC high-risk patient | Radiation: Low radiation dose CT<br>* Underwent liver CT with 30% lower radiation dose<br>Drug: Low contrast dose CT<br>* Underwent liver CT 20% lower dose contrast media.<br>* Other names: Low contrast medium dosage;Other: Deep-learning based contrast boosting algorithms<br>* Applied deep-learning based contrast boosting algorithms on acquired CT images<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of solid focal lesion in liver | diagnostic performance | 12 months after last patient's image work up | 
| Quantitative image quality analysis | Contrast-to-Noise | Immediate after study enrollement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CT