Simplified radioembolization for small liver cancer
Streamlining Radioembolization for HCC ≤ 5 cm With Y90 Resin Microspheres : Multicenter Prospective Registry Study
We will try giving radioembolization without a pre-treatment MAA scan in adults with small (≤5 cm), limited hepatocellular carcinoma and low-risk imaging features to see if the approach is safe and practical.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 146 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 4 sites (Goyang and 3 other locations) |
| Trial ID | NCT06979219 on ClinicalTrials.gov |
What this trial studies
This is a prospective registry that enrolls adults with hepatocellular carcinoma 5 cm or smaller, no more than three tumors, Child-Pugh A status, and imaging features that suggest a low lung shunt risk. Eligible patients receive radioembolization with SIR-Spheres without a pre-procedure MAA scan, and clinical and imaging outcomes are recorded over follow-up. The registry documents safety (including lung and liver toxicities), technical success, and procedural workflow outcomes to determine whether the selection criteria reliably identify patients who can skip MAA scanning. The goal is to streamline care for a defined low-risk subgroup while monitoring for any unexpected adverse events.
Who should consider this trial
Good fit: Adults with HCC confirmed by histology or LI-RADS 4–5, tumor(s) ≤5 cm and ≤3 in number, no dysmorphic intratumoral vessel ≥3 mm, no signs of high lung shunt (eg, TIPS or hepatic vein invasion/enhancement), Child-Pugh A, ECOG 0–1, and meeting the listed lab criteria are ideal candidates.
Not a fit: Patients with larger or more numerous tumors, signs of high lung shunt (TIPS, hepatic vein invasion/enhancement, large intratumoral vessels), poorer liver function (Child-Pugh B/C), or poor performance status are unlikely to benefit from skipping the MAA scan.
Why it matters
Potential benefit: If successful, this approach could shorten pre-treatment planning, reduce procedure steps and costs, and allow faster delivery of radioembolization for selected patients without increasing risk.
How similar studies have performed: Some retrospective series and small prospective reports have suggested select low-risk patients can safely omit the MAA scan, but large prospective confirmation is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Goyang and 3 other locations
- National Cancer Center — Goyang, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Not_yet_recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Severance hospital — Seoul, South Korea (Not_yet_recruiting)
Study contacts
- Study coordinator: Hyo-Cheol Kim, MD
- Email: radioembolization@snu.ac.kr
- Phone: 82-10-5136-5205
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.