N/A
N=407
Gadoxetic Acid-MRI Versus Ultrasonography for the Surveillance of Hepatocellular Carcinoma in High-risk Patients
Cirrhosis of Liver
Bottom Line
View on ClinicalTrials.gov: NCT01446666 ↗Enrolled (actual)
407
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcome: Primary: Detection Rate of Patients With HCC — 27.9; 86.0 percentage of HCC detected on each exam — p=<0.01
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Asan Medical Center
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Detection Rate of Patients With HCC |
27.9; 86.0 | <0.01 sig |
| SECONDARY Detection Rate of Patients With Early Stage HCC |
26.2; 85.7 | <0.01 sig |
| SECONDARY Detection Rate of Patients With Very Early Stage HCC |
27.3; 84.8 | <0.01 sig |
| SECONDARY False Positive Rate |
5.6; 3.0 | 0.004 sig |
| SECONDARY Positive Predictive Value for HCC |
16.9; 53.6 | — |
Summary
Current practice guidelines recommend surveillance for hepatocellular carcinoma (HCC) in liver cirrhosis patients with ultrasonography (USG) every 6 months. However, with the advancement of cirrhosis, the sensitivity of USG decreases, while the risk for HCC increases. Gadoxetic acid (Primovist®)-enhanced magnetic resonance imaging (MRI) has been demonstrated to be of clinical value for diagnosis of HCC with the detection sensitivity of 90-95%, which is significantly higher than USG. The hypothesis to be proved by this study is as follows; Primovist-MRI should show significantly higher sensitivity compared to USG for the detection of early stage HCC when both of these imaging modalities are used with the interval of 6 months in patients with cirrhosis at high risk of developing HCC.
Eligibility 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, including any of followings;
- The identification of splenomegaly on USG, CT, or MRI examinations with typical features of cirrhosis
- The identification of esophageal or gastric varices on endoscopic examination
- High Risk Index (>=2.33); Risk Index = 1.65 (if the prothrombin activity is 20% within 2 years
- Child-Pugh score >9
- Significant medical comorbidities in which survival is predicted to be less than 3 years
- Estimated glomerular filtration rate (GFR) < 30 mL/min/1.73m2
- 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.
Data sourced from ClinicalTrials.gov (NCT01446666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.