RecruitingNCT06979219
Streamlining Radioembolization for Small HCC
Streamlining Radioembolization for HCC ≤ 5 cm With Y90 Resin Microspheres : Multicenter Prospective Registry Study
Sponsor
Seoul National University Hospital
Enrollment
146 participants
Start Date
Jun 10, 2025
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 19 Years
Inclusion Criteria6
- 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 Criteria7
- 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
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06979219
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