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Same-day Radioembolization for Large HCC
RECRUITINGSponsored by Seoul National University Hospital
Actively Recruiting
SponsorSeoul National University Hospital
Started2025-04-25
Est. completion2028-12-31
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06944483
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), planning angiography, MAA scan, and radioembolization are performed in a single day with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and same-day 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 larger * 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 enterobiliary anastomosis
Conditions4
CancerHepatocellular Carcinoma (HCC)Liver CancerLiver Disease
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Actively Recruiting
SponsorSeoul National University Hospital
Started2025-04-25
Est. completion2028-12-31
Eligibility
Age19 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06944483