Abbreviated MRI for HCC Surveillance

Hepatocellular Carcinoma Clinical Trial

Official title:

MR Value: Clinical Feasibility of Abbreviated MR Protocol for HCC Surveillance in High-risk Group

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03731923
• Other study ID #: SNUH-2018-1426
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to investigate the clinical feasibility of abbreviated liver MRI for HCC surveillance in a high-risk group.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 257
• Est. completion date: December 31, 2023
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• high risk of HCC development (chronic hepatitis B, chronic hepatitis C, liver cirrhosis)

• no history of HCC

• on surveillance of HCC using ultrasonography

• sign informed consent

Exclusion Criteria:

• history of HCC

• congestive hepatopathy

• iron deposition

• any absolute or relative contra-indication of contrast-enhanced MRI

Related Conditions & MeSH terms

• Chronic Hepatitis
• Hepatocellular Carcinoma
• Liver Cirrhosis

Intervention

Diagnostic Test:
• Biannual ultrasonography
Biannual liver ultrasonography for HCC surveillance, without contrast agent.
• Annual abbreviated liver MRI
Abbreviated liver MRI using standard dose of extracellular contrast agent (Dotarem, Guerbet, France) on weight-based dosing. Table time targets 10 minutes.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Guerbet

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity for detecting HCC	Sensitivity for detecting HCC	12 months after last MRI
Secondary	Table time of abbreviated MRI	time from scan start and scan end	1 day after each MRI
Secondary	In-room time of abbreviated MRI	interval between participants' walk-in and walk-out times	1 day after each MRI
Secondary	Specificity for detecting HCC	Specificity for detecting HCC	12 months after last MRI
Secondary	Sensitivity for detecting early stage HCC	Sensitivity for detecting early stage HCC (=3cm, =3 tumors, or =5cm single tumor)	12 months after last MRI
Secondary	Specificity for detecting early stage HCC	Specificity for detecting early stage HCC (=3cm, =3 tumors, or =5cm single tumor)	12 months after last MRI
Secondary	Image quality of abbreviated liver MRI	qualitative analysis on four-point scale	12 months after last MRI