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NCT06979219
Streamlining Radioembolization for Small HCC
Conditions: Hepatocellular Carcinoma (HCC)
Sex: All
Ages: 19 Years – N/A
Healthy volunteers: No
Enrollment: 146
Sponsor: Seoul National University Hospital
Location: National Cancer Center Goyang
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 Criteria
Inclusion Criteria:
* adults aged \>18 years
* Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5)
* hepatocellular carcinoma 5cm or smaller
* Tumor number is 3 or smaller
* Dysmorphic intratumoral vessel is absent or smaller than 3 mm
* 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)
* Patients with a life expectancy of \>3 mo
* Patients who have adequately understood the clinical trial and consented in writing
* Nonpregnant women of childbearing potential
Exclusion Criteria:
1. Hepatic vein invasion on CT/MRI
2. Marked enhancement of portal vein or hepatic vein on arterial phase of CT/MRI
3. Dysmorphic intratumoral vessel ≥3mm
4. Patient with transjugular intrahepatic portosystemic shunt
5. Patient with bilioenteric anastomosis or biliary stent
6. Patient with centrilobular emphysema or interstitial lung disease
7. main portal vein invasion
Source: ClinicalTrials.gov (NCT06979219). StuddyBuddy aggregates publicly available trial information.