Non-contrast Abbreviated MRI for Secondary Surveillance of HCC

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05690451
• Other study ID #: H-2106-183-1230
• Secondary ID: KCT0006395
• Status: Recruiting
• Start date: December 28, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: Dong Ho Lee, M.D.
• Phone: 82-2-2072-0348
• Email: dhlee.rad[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Diagnostic Test:
• non-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
• Contrast 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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Korea (the Republic Of)
Korea, Republic of	Asan Medical Center	Seoul	Korea (the Republic Of)
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy per patient	Accuracy for detection of recurrent HCC per patient	Within 6 months from the study completion
Secondary	Specificity per patient	Specificity for detection of recurrent HCC per patient	Within 6 months from the study completion
Secondary	Sensitivity per patient	Sensitivity for detection of recurrent HCC per patient	Within 6 months from the study completion