"Double Low-Dose" DECT for HCC Imaging

NCT ID: NCT03045445

Last Updated: 2021-03-19

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

2017-05-30

Study Completion Date

2019-09-25

Brief Summary

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Hypothesis: double low-dose protocol provide better lesion conspicuity than standard protocol CT in patients at high-risk of HCC.

patients who are scheduled for CECT for HCC diagnosis or surveillance are eligible for this study and allocated to either standard protocol or double-low dose protocol using spectral CT with low radiation dose and low dose of contrast media, within clinically accpetable range.

Detailed Description

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Conditions

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HCC

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Double Low-Dose protocol CT

Low radiation dose + low amount of iodine contrast media at spectral CT (Philips Healthcare)

Group Type EXPERIMENTAL

Double Low-Dose protocol CT

Intervention Type DIAGNOSTIC_TEST

Double low-dose protocol CT (Low radiation dose quadriphasic liver CT and low dose of iodine contrast media) at spectral dual energy CT scanner

Standard protocol CT

Standard protocol quadriphasic liver CT according to current liver CT protocol in our institution, at spectral CT (Philips Healthcare)

Group Type ACTIVE_COMPARATOR

Standard protocol CT

Intervention Type DIAGNOSTIC_TEST

standard protocol CT (standard dose quadriphasic liver CT and standard dose of iodine contrast media) at spectral dual energy CT scanner

Interventions

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Double Low-Dose protocol CT

Double low-dose protocol CT (Low radiation dose quadriphasic liver CT and low dose of iodine contrast media) at spectral dual energy CT scanner

Intervention Type DIAGNOSTIC_TEST

Standard protocol CT

standard protocol CT (standard dose quadriphasic liver CT and standard dose of iodine contrast media) at spectral dual energy CT scanner

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* high risk of HCC (chronic hepatitis B or C, or LC of any cause)
* signed informed consent
* scheduled for contrast enhanced liver CT for HCC surveillance or diagnosis

Exclusion Criteria

* no risk factor for HCC
* history of iodine hypersensitivity
* renal dysfunction (Estimated GFR \< 30mL/min/1.73m2) or on dialysis
* metformin medication within 48 hours
* any other contraindication of CE-CT
* BMI \> or = 30
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Philips Healthcare

INDUSTRY

Sponsor Role collaborator

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

References

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Yoon JH, Chang W, Lee ES, Lee SM, Lee JM. Double Low-Dose Dual-Energy Liver CT in Patients at High-Risk of HCC: A Prospective, Randomized, Single-Center Study. Invest Radiol. 2020 Jun;55(6):340-348. doi: 10.1097/RLI.0000000000000643.

Reference Type DERIVED
PMID: 31917765 (View on PubMed)

Other Identifiers

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SNUH-2016-2830

Identifier Type: -

Identifier Source: org_study_id

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