A prospective open intra-individual comparative cohort study to investigate the performance characteristics of Gadoxetic Acid (Primovist®)-enhanced MRI and Ultrasonography for the surveillance of early stage HCC in patients with liver cirrhosis at high-risk

• Register: KCT
• Last refreshed on: 27 April 2013
• Main ID: KCT0000277
• Date of registration: 25/11/2011
• Primary sponsor: Bayer
• Public title: A prospective open intra-individual comparative cohort study to investigate the performance characteristics of Gadoxetic Acid (Primovist®)-enhanced MRI and Ultrasonography for the surveillance of early stage HCC in patients with liver cirrhosis at high-risk
• Scientific title: A prospective open intra-individual comparative cohort study to investigate the performance characteristics of Gadoxetic Acid (Primovist®)-enhanced MRI and Ultrasonography for the surveillance of early stage HCC in patients with liver cirrhosis at high-risk
• Date of first enrolment: 2011-11-23
• Target sample size: 423
• Recruitment status: Recruiting
• URL: http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=2148
• Study type: Observational Study
• Study design: Observational Study Model : Cohort, Time Perspective : Prospective, Enrollment : 423, Biospecimen Retention : Retained - Sample with DNA, Biospecimen Description : Peripheral blood buffy coat and serum

Countries of recruitment

Korea, Republic of

Contacts

• Name: Ji-Young Lee
• Affiliation: Asan Medical Center

• Name: Young-Suk Lim
• Affiliation: Asan Medical Center

Key inclusion & exclusion criteria

Inclusion criteria: Patients with liver cirrhosis with the 1-year risk of HCC of 5% or higher meeting all of following criteria;
- The evidence of cirrhosis of any etiology within 12 months prior to screening
; Definition of cirrhosis by any of following methods;
1) Histologically by liver biopsy
2) Non-histologically by evidence of portal hypertension in the presence of chronic liver disease
- Evidence of portal hypertension includes any of followings;
1) The identification of splenomegaly on USG, CT, or MRI examinations with typical features of cirrhosis
2) The identification of esophageal or gastric varices on endoscopic examination
- High Risk Index (=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 anti-HCV or HBsAg is positive).
- Older than 20 years of age
- Absence of previous or current history of HCC
- Absence of HCC should be identified by liver USG, dynamic CT, or contrast-enhanced MRI within 6 months prior to screening
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2
- Patient is able to comply with scheduled visits, evaluation plans, and other study procedures.
- Patient is willing to provide written informed consent
Exclusion criteria: Presence of any of following criteria;
- Active or suspected cancer other than HCC, or a history of malignancy where the risk of recurrence is >20% within 2 years
- Significant medical comorbidities in which survival is predicted to be less than 3 years
- Estimated GFR < 30 mL/min/1.73m2
- Estimated GFR by Modification of Diet in Renal Disease (MDRD) equation 25; GFR (ml/min/1.73 m2) = 175 × serum creatinine?1.154 × age?0.203 × 1.212 (if black) × 0.742 (if female)
- Precautions for MRI (cardiac pacemaker, ferromagnetic implants, etc.)
- Severe claustrophobia that may interfere with protocol compliance.
- Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrollment or could interfere with the completing the study.


Age minimum: 20(Year)
Age maximum: (Year)
Gender: Both

Health Condition(s) or Problem(s) studied

Diseases of the digestive system

Primary Outcome(s)

The detection sensitivity of early stage HCC

Secondary Outcome(s)

The cost-effectiveness for each surveillance tests

The detection sensitivity of all stage HCC

The detection sensitivity of patients with early stage HCC

The detection sensitivity of very early stage HCC

The detection specificity for all stage HCC

Secondary ID(s)

NCT01446666

Secondary Sponsor(s)

Asan Medical Center