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CompletedNCT05690451Updated Jun 25, 2024

Non-contrast Abbreviated MRI for Secondary Surveillance of HCC

An observational study in Hepatocellular Carcinoma, sponsored by Seoul National University Hospital. Completed at 3 sites in South Korea. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-06-25.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
210
Ages
20 Years to 85 Years
Sex
All
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Study summary

This prospective multicenter study aimed to compare the diagnostic performance of non-contrast abbreviated MRI in detecting recurrent HCC after curative treatment to that of contrast-enhanced liver CT.

Read the detailed description

This study was designed as a prospective single-arm intra-individual comparison multicenter study

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Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Secondary surveillance of hepatocellular carcinoma
  • Contrast enhanced liver CT
  • non-contrast abbreviated MRI
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In context

Carcinoma, Hepatocellular

3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's enrollment of 210 is close to the median of 200 across 769 observational studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 85 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients who underwent curative treatment for HCC including surgical resection or local ablation and have a more than a two-year disease-free period, needing continuous surveillance for the development of HCC will be candidates for this study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age between 20-year old and 85-year old
  • Patients with a history of curative treatment for HCC including surgical resection or local ablation
  • No recurrence after curative treatment of HCC for more than two years
  • Patient who has the plan to perform contrast-enhanced liver CT for secondary surveillance for HCC (i.e., to detect de novo or recurrent HCC)

Exclusion criteria

Exclusion Criteria:

  • Estimated GFR less than 60
  • Previous history of severe allergic reaction to the iodinated contrast agent
  • Patients with claustrophobia who can't undergo MR examination
  • Patients having cochlear implants or cardiac pacemaker
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
210 participants (actual)
Target follow-up
24 Months
Patient registry
Yes

Interventions

  • Diagnostic testnon-contrast abbreviated MRI

    Liver MRI without contrast injection. The following sequences will be obtained from all of the participants. * Axial heavily and regular T2 WI * precontrast fat-suppressed T1 WI * Diffusion-weighted image using b-value of 0, 50 or 400, and 800 or 1000

  • Diagnostic testContrast enhanced liver CT

    Liver CT with iodine contrast injection This test will be served as a standard diagnostic test. The following phases will be obtained * precontast, arterial phase, portal venous phase and delayed phase

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What researchers measure

Primary outcomes

  1. Accuracy per patient

    Accuracy for detection of recurrent HCC per patient

    Time frame: Within 6 months from the study completion

Secondary outcomes

  1. Specificity per patient

    Specificity for detection of recurrent HCC per patient

    Time frame: Within 6 months from the study completion

  2. Sensitivity per patient

    Sensitivity for detection of recurrent HCC per patient

    Time frame: Within 6 months from the study completion

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Study locations

3 sites
  • Seoul National University Bundang Hospital
    Seongnam, Korea (the Republic Of) 13620, South Korea
  • Asan Medical Center
    Seoul, Korea (the Republic Of) 05505, South Korea
  • Seoul National University Hospital
    Seoul, 03080, South Korea
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References and documents

Individual participant data

Plan to share: Undecided — Individual participant data (IPD) of this study will be available for reasonable requests after approval of IRB

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2021 to primary completion in Jun 2024, 29 months.

Of 273 non-industry observational studies under Carcinoma, Hepatocellular, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 112. This study's 29 months is below that.

Counting every sponsor, half of 313 studies reached it within 50 months; a quarter within 32 and three quarters within 98.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 28, 2022
First posted
Jan 19, 2023
StartActual
Dec 28, 2021
Primary completionActual
Jun 22, 2024
CompletionActual
Jun 22, 2024
Last update
Jun 25, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05690451
Responsible party
Dong Ho Lee (Clinical professor, Seoul National University Hospital) — Principal investigator
First posted
Jan 19, 2023
Start date
Dec 28, 2021
Primary completion
Jun 22, 2024
Completion
Jun 22, 2024
Last update
Jun 25, 2024

Study contacts

Dong Ho Lee, M.D.
principal investigator · Seoul National University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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