NCT03045445

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 4, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

May 30, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2018

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2019

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

10 months

First QC Date

February 4, 2017

Last Update Submit

March 18, 2021

Conditions

HCC

Keywords

CTdual energylow dose

Outcome Measures

Primary Outcomes (1)

  • Lesion conspicuity

    qualitative conspicuity assessment of focal liver lesion

    12 months after CT

Secondary Outcomes (9)

  • image noise

    12 months after CT

  • beam hardening artifact

    12 months after CT

  • hepatic artery conspicuity

    12 months after CT

  • portal vein conspicuity

    12 months after CT

  • image texture (plasticity)

    12 months after CT

  • +4 more secondary outcomes

Other Outcomes (3)

  • contrast media iodine amount

    1 month after CT

  • adverse effect

    1 month after CT

  • Enhancement degree

    12 months after CT

Study Arms (2)

Double Low-Dose protocol CT

EXPERIMENTAL

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

Diagnostic Test: Double Low-Dose protocol CT

Standard protocol CT

ACTIVE COMPARATOR

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

Diagnostic Test: Standard protocol CT

Interventions

Double Low-Dose protocol CTDIAGNOSTIC_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

Double Low-Dose protocol CT
Standard protocol CTDIAGNOSTIC_TEST

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

Standard protocol CT

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 31917765DERIVED

Study Officials

  • Jeong Min Lee, MD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 4, 2017

First Posted

February 7, 2017

Study Start

May 30, 2017

Primary Completion

March 21, 2018

Study Completion

September 25, 2019

Last Updated

March 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)