Clinical trial NCT03892681: Hepatocyte-specific Versus Extracellular Contrast Agents for Liver MRI: Prospective, Intra-individual Comparison of Diagnostic Performance for Hepatocellular Carcinoma
Official title: Hepatocyte-specific Versus Extracellular Contrast Agents for Liver MRI: Prospective, Intra-individual Comparison of Diagnostic Performance for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis
Liver Cirrhosis
Keywords: HBsAg(+) with chronic hepatitis or cirrhosis
anti-HCV(+) with cirrhosis
cirrhosis of any etiology
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 129
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Adult patients with chronic hepatitis B and cirrhosis of any etiology who are found to have suspected liver cancer are potentially eligible for the study. All enrolled patients will undergo two MRI scans using two different contrast agents. The type of contrast agent for the 1st MRI will be performed using hepatocyte-specific contrast agent. The participant will undergo the 2nd MRI using extracellular contrast agent. The MRI examinations will be independently interpreted by two different radiologists. The radiologists will evaluate focal hepatic lesions and categorize them according to the LI-RADS v2018 and EASL 2018. Once the diagnosis is made, the participants will be provided with the standard of care. After the initial treatment, the participants will be followed up with multi-phasic dynamic contrast-enhanced CT every 3 or 6 months for at least 2 years. Based on the prospectively written radiology reports, the diagnostic performances will be calculated and compared between MRI with hepatocyte-specific contrast agent and MRI with extracellular contrast agent, using the pathology and clinical criteria as the reference standard.


Eligibility criteria: Inclusion Criteria:

1. Older than 20 years
2. HBsAg (+) with chronic hepatitis or cirrhosis, anti-HCV (+) with cirrhosis, or cirrhosis of any etiology

   * The presence of cirrhosis will be determined based on the histologic or radiologic findings, including liver surface nodularity, margin blunting, segmental hypertrophy/atrophy, and findings secondary to portal hypertension (i.e., splenomegaly, esophageal or gastric varices, ascites, or reverse portal vein flow).
3. Child-Pugh class A or B
4. Up to three suspicious focal lesions between 10 mm and 30 mm found on US, CT, or MRI

   * Patients with a history of HCC treated by surgery or tumor ablation could be included, but only new nodules at a distance of \> 2 cm from previously treated lesions were considered.

Exclusion Criteria:

1. Currently pregnant or lactating
2. Risk group for the use of gadolinium-enhanced MRI including severely decreased renal function (stage 4 or 5 chronic renal failure with eGFR ˂ 30 mL/min/1.73 m2), claustrophobia
3. Patients with history of chemoembolization or systemic treatment for liver cancer

Primary outcomes:
measure: Sensitivity
timeFrame: an expected average of 2 weeks
measure: Specificity
timeFrame: an expected average of 2 weeks
Secondary outcomes:
measure: Inter-reader agreement between two radiologists
timeFrame: an expected average of 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
References: