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Streamlining Radioembolization for Small HCC
RECRUITINGSponsored by Seoul National University Hospital
Actively Recruiting
SponsorSeoul National University Hospital
Started2025-06-10
Est. completion2028-12-31
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06979219
Summary
In patients who has no sign suggesting high lung shunt fraction (TIPS, hepatic vein invasion, hepatic vein enhancement on arterial phase, dysmorphic intratumoral vessel, tumor size \< 5cm), radioembolization is performed without MAA scan with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and streamlining radioembolization is feasible and safe.
Eligibility
Age: 19 Years+Healthy volunteers accepted
Inclusion Criteria: * HCC can be diagnosed by AASLD guideline * hepatocellular carcinoma 5cm or smaller * dysmorphic intratumoral vessels 3mm or smaller * Child-Pugh class A * ECOG 0 or 1 * the following lab should be met. A. Leukocytes ≥ 1,000/µL and ≤ 20,000/µL B. Hemoglobin ≥ 6.0 g/dL (transfusion allowed to meet this criterion) C. Total bilirubin ≤ 2.0 mg/dL D. Platelet ≥ 40,000/µL E. International normalized ratio (INR) ≤ 2.0 for patients not taking anticoagulants F. Aspartate transaminase (AST) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) G. Alanine transaminase (ALT) ≤ 800 IU/L (i.e., ≤ 20X upper normal limit) H. Creatinine ≤ 2.5 mg/dL (if patient is receiving hemodialysis, no upper limit of creatinine) Exclusion Criteria: * hepatic vein invasion on CT/MRI * hepatic vein enhancement on arterial phase of CT/MRI * TIPS * dysmorphic intratumoral vessels \> 3mm * main portal vein invasion * significant COPD or interstitial lung disease * biliary stent or bilioenteric anastomosis
Conditions4
CancerHepatocellular Carcinoma (HCC)Liver CancerLiver Disease
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Actively Recruiting
SponsorSeoul National University Hospital
Started2025-06-10
Est. completion2028-12-31
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06979219