Cirrhosis, Hepatocellular Carcinoma
Conditions
Keywords
MRI, HCC, surveillance
Brief 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.
Detailed 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.
Interventions
PROCEDUREBiannual ultrasonography
Biannual ultrasonography for HCC surveillance, performed by board-certified radiologists.
PROCEDUREAnnual 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.
PROCEDUREContrast enhanced liver CT
In patients without report of HCC during surveillance period, contrast CT is performed 6 months after the last MR scan.
Sponsors
Seoul National University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sensitivity for detecting HCC | 6 months after last patient's MRI |
Secondary
| Measure | Time frame |
|---|---|
| specificity for detecting HCC | 6 months after last patient's MRI |
Other
| Measure | Time frame | Description |
|---|---|---|
| Apparent diffusion coefficient (ADC) | 1 month after each MR scan | calculated value from diffusion weighted image with different protocols (conventional, simultaneous multishot) |
| T2 relaxation time | 1 month after MR scan | calculated value from T2 map |
Countries
South Korea
Outcome results
None listed