Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging for HCC Surveillance

Hepatocellular Carcinoma Clinical Trial

Official title:

Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging as a Surveillance Test for HCC in Patients With Liver Cirrhosis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02854241
• Other study ID #: SNUH-2016-0174
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: June 2022

Study information

• Verified date: March 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography.

Description:

The purpose of this study is to investigate clinical feasibility of annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma in high-risk group, in comparison with biannual ultrasonography. In addition, the relationship between non-contrast MR parameters and clinical manifestation of liver function is investigated.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• equal to or older than 40 years
• under surveillance using biannual ultrasonography (USG) and presence of liver USG within 6 months (+/- 1month)
• risk index is equal to or higher than 2.33 (Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100x10(3)/mm3) + 0.74 (if the presence of HCV or HBsAg is positive)).
• signed informed consent

Exclusion Criteria:

• under 40 years
• history of HCC
• patients with pregnancy or nursing
• any contraindication of MRI
• any contraindication of CT

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cirrhosis
• Fibrosis
• Hepatocellular Carcinoma
• Liver Cirrhosis

Intervention

Procedure:
• Biannual ultrasonography
Biannual ultrasonography for HCC surveillance, performed by board-certified radiologists.
• Annual noncontrast liver MRI
Annual noncontrast liver MRI consisted of T2WI, precontrast T1WI, dual-echo image, DWI (single shot, multishot) and T2 map. DWI using multishot and T2 map are not included for initial MR reading.
• Contrast enhanced liver CT
In patients without report of HCC during surveillance period, contrast CT is performed 6 months after the last MR scan.

Locations

Country	Name	City	State
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
Other	Apparent diffusion coefficient (ADC)	calculated value from diffusion weighted image with different protocols (conventional, simultaneous multishot)	1 month after each MR scan
Other	T2 relaxation time	calculated value from T2 map	1 month after MR scan
Primary	sensitivity for detecting HCC		6 months after last patient's MRI
Secondary	specificity for detecting HCC		6 months after last patient's MRI