NCT06979219 Streamlining Radioembolization for Small HCC
| NCT ID | NCT06979219 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Seoul National University Hospital |
| Condition | Hepatocellular Carcinoma (HCC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 146 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 146 participants in total. It began in 2025-06-10 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06979219 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Hepatocellular Carcinoma (HCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06979219 currently recruiting?
Yes, NCT06979219 is actively recruiting participants. Contact the research team at radioembolization@snu.ac.kr for enrollment information.
Where is the NCT06979219 trial being conducted?
This trial is being conducted at Goyang, South Korea, Seoul, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT06979219 clinical trial?
NCT06979219 is sponsored by Seoul National University Hospital. The trial plans to enroll 146 participants.
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