Fact CheckerSign in

NCT06979219Recruiting

Streamlining Radioembolization for Small HCC

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

Source: ClinicalTrials.gov · Last updated 18 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
146 (estimated)
First submitted
11 May 2025
Start date
10 Jun 2025
Primary completion date
31 Dec 2028
Lead sponsor
Seoul National University Hospital
NCT number
NCT06979219

What you commit to

  • Study type: Observational
  • Planned participants: 146
  • From 10 Jun 2025 to the primary completion date, 31 Dec 2028
  • 5 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patient with centrilobular emphysema or interstitial lung disease

Other

  • Hepatic vein invasion on CT/MRI
  • Marked enhancement of portal vein or hepatic vein on arterial phase of CT/MRI
  • Dysmorphic intratumoral vessel ≥3mm
  • Patient with transjugular intrahepatic portosystemic shunt
  • Patient with bilioenteric anastomosis or biliary stent
  • main portal vein invasion

Who the study is looking for

  • 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

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Cancer Center
Coordinator of this site? Confirm its status
GoyangSouth KoreaRecruiting
Seoul National University Bundang Hospital
Coordinator of this site? Confirm its status
Seongnam-siSouth KoreaRecruiting
Severance hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaNot yet recruiting
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaRecruiting
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.