NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Streamlining Radioembolization for Small HCC

RecruitingN/A

Sponsor: Seoul National University Hospital

Conditions: Hepatocellular Carcinoma (HCC)

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, 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.

Eligibility overview

Sex: ALL

Age: 19 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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

Locations (5)

Goyang, South Korea
Seongnam-si, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea