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

NCT04722120 | Completed DMC

• 1 other identifier: SNUH-2016-2272
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

CT

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Conventional liver CT

ACTIVE COMPARATOR

Underwent conventional liver CT on HCC high-risk patient

Radiation: Conventional CT (radiation); Drug: Conventional CT (contrast agent)

Double low dose CT

EXPERIMENTAL

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; Drug: Low contrast dose CT; Other: Deep-learning based contrast boosting algorithms

Interventions

Low radiation dose CT RADIATION

Underwent liver CT with 30% lower radiation dose

Double low dose CT

Conventional CT (radiation) RADIATION

Underwent liver CT without change of radiation.

Conventional liver CT

Low contrast dose CT DRUG

Underwent liver CT 20% lower dose contrast media.

Also known as: Low contrast medium dosage

Double low dose CT

Conventional CT (contrast agent) DRUG

Underwent liver CT without change of contrast media doses.

Also known as: Standard contrast medium dosage

Conventional liver CT

Deep-learning based contrast boosting algorithms OTHER

Applied deep-learning based contrast boosting algorithms on acquired CT images

Double low dose CT

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver cirrhosis
• Tumor marker (aFP, PIVKA) elevation
• Nodular lesion on USG
• Received RFA for HCC

You may not qualify if:

• hypersensitivity at iodine
• GFR under 30
• BMI over 30
• Nursing or pregnant women
• enrolled the other study

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Congresses as Topic; Radiation; Contrast Media

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations; Physical Phenomena; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Jeong Min Lee, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Participants, investigators, and outcome assessors were all masked to the allocation
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: January 25, 2021
• Study Start: June 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2021
• Last Updated: February 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)