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

NCT ID: NCT04722120

Last Updated: 2022-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2021-01-01

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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Caregivers
Participants, investigators, and outcome assessors were all masked to the allocation

Study Groups

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Conventional liver CT

Underwent conventional liver CT on HCC high-risk patient

Group Type ACTIVE_COMPARATOR

Conventional CT (radiation)

Intervention Type RADIATION

Underwent liver CT without change of radiation.

Conventional CT (contrast agent)

Intervention Type DRUG

Underwent liver CT without change of contrast media doses.

Double low dose CT

Underwent double low dose liver CT with 30% lower radiation dose and 20% contrast media on HCC high-risk patient

Group Type EXPERIMENTAL

Low radiation dose CT

Intervention Type RADIATION

Underwent liver CT with 30% lower radiation dose

Low contrast dose CT

Intervention Type DRUG

Underwent liver CT 20% lower dose contrast media.

Deep-learning based contrast boosting algorithms

Intervention Type OTHER

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

Interventions

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Low radiation dose CT

Underwent liver CT with 30% lower radiation dose

Intervention Type RADIATION

Conventional CT (radiation)

Underwent liver CT without change of radiation.

Intervention Type RADIATION

Low contrast dose CT

Underwent liver CT 20% lower dose contrast media.

Intervention Type DRUG

Conventional CT (contrast agent)

Underwent liver CT without change of contrast media doses.

Intervention Type DRUG

Deep-learning based contrast boosting algorithms

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

Intervention Type OTHER

Other Intervention Names

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Low contrast medium dosage Standard contrast medium dosage

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jeong Min Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeong Min Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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SNUH-2016-2272

Identifier Type: -

Identifier Source: org_study_id

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