Gadoxetic Acid-MRI Versus Ultrasonography for the Surveillance of Hepatocellular Carcinoma in High-risk Patients

NCT01446666 | Completed Results DMC

• 1 other identifier: AMC2011-0587
• Study Type: observational
• Target: 423
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cirrhosis of Liver

Keywords

hepatocellular carcinoma; surveillance; gadoxetic acid; MRI

Outcome Measures

Primary Outcomes (1)

• Detection Rate of Patients With HCC

  \- The number of patients with definite HCC detected by a given modality divided by the total number of patients with definite HCC detected by any of 2 modalities plus interval cancers

  during the 1.5-year study period (from the date of first screening to 6 months following the last screening)

Secondary Outcomes (4)

• Detection Rate of Patients With Early Stage HCC

  during the 1.5-year study period (from the date of first screening to 6 months following the last screening)

• Detection Rate of Patients With Very Early Stage HCC

  during the 1.5-year study period (from the date of first screening to 6 months following the last screening)

• False Positive Rate

  during the 1.5-year study period (from the date of first screening to 6 months following the last screening)

• Positive Predictive Value for HCC

  during the 1.5-year study period (from the date of first screening to 6 months following the last screening)

Study Arms (1)

HCC high-risk group

Patients with liver cirrhosis with the 1-year risk of HCC of 5% or higher ; 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-hepatitis C virus \[HCV\] or hepatitis B surface antigen \[HBsAg\] is positive).

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Hospital out-patient clinic

You may qualify if:

• 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
• \) Histologically by liver biopsy;
• \) 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 \<=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-hepatitis C virus \[HCV\] or hepatitis B surface antigen \[HBsAg\] 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Asan Medical Center: lead
• Bayer: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 135-837, South Korea

Location

Related Publications (2)

• Kim HL, An J, Park JA, Park SH, Lim YS, Lee EK. Magnetic Resonance Imaging Is Cost-Effective for Hepatocellular Carcinoma Surveillance in High-Risk Patients With Cirrhosis. Hepatology. 2019 Apr;69(4):1599-1613. doi: 10.1002/hep.30330. Epub 2019 Feb 25.

  PMID: 30365164 DERIVED

• Kim SY, An J, Lim YS, Han S, Lee JY, Byun JH, Won HJ, Lee SJ, Lee HC, Lee YS. MRI With Liver-Specific Contrast for Surveillance of Patients With Cirrhosis at High Risk of Hepatocellular Carcinoma. JAMA Oncol. 2017 Apr 1;3(4):456-463. doi: 10.1001/jamaoncol.2016.3147.

  PMID: 27657493 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Buffy coat and serum

MeSH Terms

Conditions

Fibrosis; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: Professor Young-Suk Lim
• Organization: Asan Medical Center, University of Ulsan College of Medicine

limys@amc.seoul.kr

+82-02-3010-5933

Study Officials

• Young-Suk Lim, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 17, 2011
• First Posted: October 5, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 1, 2019
• Results First Posted: January 14, 2019

Record last verified: 2019-01

Locations

KR (1)