Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07476651
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 19 years or older
* Hepatocellular carcinoma diagnosed radiologically according to the American Association for the Study of Liver Disease diagnostic criteria or diagnosed histologically, histologically diagnosed intrahepatic cholangiocarcinoma, or liver metastases
* Volume of liver not included in the treatment field is at least 30% of the total non-tumorous liver volume
* Child-Pugh class A
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 ⑥ Patients with lung shunt fraction ≤20% on MAA scan (planar image)
⑦ Patients with no major organ abnormalities on blood tests performed within 2 months before treatment:
• 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 (no restriction for dialysis patients) ⑧ Patients with life expectancy of at least 3 months ⑨ For women of childbearing potential, those with negative serum pregnancy test ⑩ Patients who fully understand the content of the prospective observational study and provide written informed consent
Exclusion Criteria:
1. Patients with biliary-enteric anastomosis or biliary stent
2. Cases where the operator judges that even mild radiation pneumonitis could be fatal due to findings of emphysema or interstitial lung disease on chest CT
3. Patients with a history of severe hypersensitivity reaction to iodinated contrast agents
4. Patients with contraindications to angiography or catheter manipulation
5. Patients with lung shunt fraction \>20% on MAA scan (planar image)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT07476651
Study Brief:
Protocol Section:
NCT07476651