Non-contrast Abbreviated MRI for Secondary Surveillance of HCC

NCT05690451 | Completed

• 2 other identifiers: H-2106-183-1230KCT0006395
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Hepatocellular Carcinoma

Keywords

Secondary surveillance of hepatocellular carcinoma; Contrast enhanced liver CT; non-contrast abbreviated MRI

Outcome Measures

Primary Outcomes (1)

• Accuracy per patient

  Accuracy for detection of recurrent HCC per patient

  Within 6 months from the study completion

Secondary Outcomes (2)

• Specificity per patient

  Within 6 months from the study completion

• Sensitivity per patient

  Within 6 months from the study completion

Interventions

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

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (3)

Seoul National University Bundang Hospital

Seongnam, Korea (the Republic Of), 13620, South Korea

Location

Asan Medical Center

Seoul, Korea (the Republic Of), 05505, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

• Dong Ho Lee, M.D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: December 28, 2022
• First Posted: January 19, 2023
• Study Start: December 28, 2021
• Primary Completion: June 22, 2024
• Study Completion: June 22, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

KR (3)