NCT06944483Recruiting
Same-day Radioembolization for Large HCC
Same-day Radioembolization for Large HCC (>5cm) 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), planning angiography, MAA scan, and radioembolization are performed in a single day with SIR-Spheres. This prospective registry will prove that the selection criteria is accurate and same-day radioembolization is feasible and safe.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 138 (estimated)
- First submitted
- 8 Apr 2025
- Start date
- 25 Apr 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06944483
What you commit to
- Study type: Observational
- Planned participants: 138
- From 25 Apr 2025 to the primary completion date, 31 Dec 2028
- 4 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
- significant COPD or interstitial lung disease
Other
- hepatic vein invasion on CT/MRI
- Marked enhancement of portal vein or hepatic vein on arterial phase of CT/MRII
- TIPS
- dysmorphic intratumoral vessels \> 3mm
- main portal vein invasion
- biliary stent or enterobiliary anastomosis
Who the study is looking for
- Patients diagnosed with hepatocellular carcinoma histologically and/or radiologically (LI-RADS 4 or 5)
- hepatocellular carcinoma 5cm or larger
- dysmorphic intratumoral vessels 3mm or smaller
- 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
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center Coordinator of this site? Confirm its status | Goyang | South Korea | Recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Not yet recruiting |
Related publications
- Same-Day Radioembolization for Large Hepatocellular Carcinoma (≥ 5 cm) Using Yttrium-90 Resin Microspheres: Protocol for a Multicenter Prospective Registry Study (ISTAR-01).Cardiovasc Intervent Radiol · 2026 · PMID 42844316
This page is information, not medical advice. Discuss any trial with your doctor.