Clinical trial · Observational
Streamlining Radioembolization for Small HCC
Streamlining Radioembolization for HCC ≤ 5 cm With Y90 Resin Microspheres : Multicenter Prospective Registry Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Streamlining group
- description
- radioembolization is performed without MAA scan
Primary outcomes (1)
- measure
- complete response rate by mRECIST
- timeFrame
- up to 1 year
- description
- the proportion of CR by mRECIST at any time of the primary target tumor
Secondary outcomes (4)
- measure
- objective response rate
- timeFrame
- up to 1 year
- measure
- local progression-free survival
- timeFrame
- From date of radioembolization until the date of first documented progression of treated tumor or date of death from any cause, whichever came first, assessed up to 60 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDGabr A, Ranganathan S, Mouli SK, Riaz A, Gates VL, Kulik L, Ganger D, Maddur H, Moore C, Hohlastos E, Katariya N, Caicedo JC, Kalyan A, Lewandowski RJ, Salem R. Streamlining radioembolization in UNOS T1/T2 hepatocellular carcinoma by eliminating lung shunt estimation. J Hepatol. 2020 Jun;72(6):1151-1158. doi: 10.1016/j.jhep.2020.02.024. Epub 2020 Mar 5. PMID 32145255
- BACKGROUNDKim HC, Suh M, Paeng JC, Lee JH, Lee M, Chung JW, Choi JW. Streamlining Radioembolization without Lung Shunt Estimation versus Regular Radioembolization in Patients with Hepatocellular Carcinoma within the Milan Criteria. J Vasc Interv Radiol. 2025 Jan;36(1):78-87.e1. doi: 10.1016/j.jvir.2024.10.007. Epub 2024 Oct 12. PMID 39401745