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

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Radiation: Conventional CT (radiation); Radiation: Low radiation dose CT; Drug: Conventional CT (contrast agent); Drug: Low contrast dose CT; Other: Deep-learning based contrast boosting algorithms

• Registration Number: NCT04722120
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-06-01
• Study First Submitted: 2016-09-08
• Primary Completion: 2018-01-01
• Study Completion: 2021-01-01
• Study First Submitted QC: 2021-01-21
• Study First Posted: 2021-01-25
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-29
• Last Update Posted: 2022-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional liver CT	Conventional CT (radiation)	Underwent conventional liver CT on HCC high-risk patient
Conventional liver CT	Conventional CT (contrast agent)	Underwent conventional liver CT on HCC high-risk patient
Double low dose CT	Low radiation dose CT	Underwent double low dose liver CT with 30% lower radiation dose and 20% contrast media on HCC high-risk patient
Double low dose CT	Low contrast dose CT	Underwent double low dose liver CT with 30% lower radiation dose and 20% contrast media on HCC high-risk patient
Double low dose CT	Deep-learning based contrast boosting algorithms	Underwent double low dose liver CT with 30% lower radiation dose and 20% contrast media on HCC high-risk patient

Primary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of