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Completed

NCT Number: NCT05690451

Non-contrast Abbreviated MRI for Secondary Surveillance of HCC

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Bundang Hospital, Seongnam, Korea (the Republic Of), South Korea

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About this study

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

Who can participate

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

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

  • 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

Treatment and study plan

non-contrast abbreviated MRI

Diagnostic Test

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

Contrast enhanced liver CT

Diagnostic Test

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

Primary outcomes

  1. Accuracy per patient

    Time frame: Within 6 months from the study completion

    Accuracy for detection of recurrent HCC per patient

Secondary outcomes

  1. Specificity per patient

    Time frame: Within 6 months from the study completion

    Specificity for detection of recurrent HCC per patient

  2. Sensitivity per patient

    Time frame: Within 6 months from the study completion

    Sensitivity for detection of recurrent HCC per patient

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Role of Non-contrast Abbreviated MRI for Secondary Surveillance of Hepatocellular Carcinoma After Curative Treatment: a Prospective Multicenter Study

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 19, 2023
Registry last updated
Jun 25, 2024

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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