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Clinical trial Recruiting at 3 sites Observational Ages 19 and up

Simplified radioembolization for small liver cancer

Official title: Streamlining Radioembolization for HCC ≤ 5 cm With Y90 Resin Microspheres : Multicenter Prospective Registry Study

Run by Seoul National University Hospital · NCT06979219 · Data updated 2026-11-12

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 typeObservational
Ages19 Years and up
SexAll
Enrollment146 (estimated)
SponsorSeoul National University Hospital
Academic / other
Locations5 sites (Goyang and 4 other locations)
StatusRecruiting
StartedJune 10, 2025
Main results expectedDecember 31, 2028
Study endsDecember 31, 2029
Registry record updatedAugust 18, 2026
Trial IDNCT06979219 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • National Cancer Center
    Goyang, South Korea     Recruiting
  • Seoul National University Bundang Hospital
    Seongnam-si, South Korea     Recruiting
  • Seoul National University Hospital
    Seoul, South Korea     Recruiting
  • Samsung Medical Center
    Seoul, South Korea     Not yet recruiting
  • Severance hospital
    Seoul, South Korea     Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Hepatocellular Carcinoma (HCC) 119Seoul National University Hospital 133
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.