NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Same-day Radioembolization for Large HCC

RecruitingN/A

Sponsor: Seoul National University Hospital

Conditions: Hepatocellular Carcinoma (HCC)

Interventions: same-day radioembolization

Countries: South Korea

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.

Eligibility overview

Sex: ALL

Age: 19 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* significant COPD or interstitial lung disease
* biliary stent or enterobiliary anastomosis

Locations (4)

Goyang, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea