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OpenTrials
Completed

NCT Number: NCT03045445

"Double Low-Dose" DECT for HCC Imaging

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.

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Key information

Conditions

HCC

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Double Low-Dose protocol CT

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

Diagnostic Test

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

Primary outcomes

  1. Lesion conspicuity

    Time frame: 12 months after CT

    qualitative conspicuity assessment of focal liver lesion

Secondary outcomes

  1. image noise

    Time frame: 12 months after CT

    qualitative analysis

  2. beam hardening artifact

    Time frame: 12 months after CT

    qualitative analysis

  3. hepatic artery conspicuity

    Time frame: 12 months after CT

    qualitative analysis

  4. portal vein conspicuity

    Time frame: 12 months after CT

    qualitative analysis

  5. image texture (plasticity)

    Time frame: 12 months after CT

    qualitative analysis

  6. overall image quality

    Time frame: 12 months after CT

    qualitative analysis

  7. presence of hepatic artery anatomic variation

    Time frame: 12 months after CT

    yes, no, indeterminate and if yes) describe the variation

  8. sensitivity to detect HCC

    Time frame: 18 months after CT

    according to LI-RADS

  9. radiation dose

    Time frame: 1 month after CT

    CTDIvol, DLP, and effective dose

Other outcomes

  1. contrast media iodine amount

    Time frame: 1 month after CT

    contrast media iodine amount

  2. adverse effect

    Time frame: 1 month after CT

    any adverse effect related with contrast media

  3. Enhancement degree

    Time frame: 12 months after CT

    HU in aorta, portal vein and liver parenchyma on each phase of CT

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Philips Healthcare

Registry information

Official study title

Comparison of Image Quality Between "Double Low-Dose" Dual Energy Liver CT and Standard Contrast Enhanced Liver CT in Patients at High-risk of HCC: Prospective, Randomized Single Center Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 7, 2017
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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