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:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT07278102
Eligibility Criteria:
Inclusion Criteria:
* A. Patients receiving TARE using TheraSphere® B. Treatment naïve BCLC 0 or A single HCC up to 8 cm (diagnosed according to diagnostic criteria of KLCA-NCC) C. Tumor involvement \< 50% of total liver volume based on dynamic CT or MRI D. Age \> or = 18 E. ECOG performance status 0 F. AST/ALT \< or = 5 times the upper limits of normal G. A life expectancy \> 3 months H. Non-pregnant with an acceptable contraception in premenopausal women I. Ability to provide written informed consent and to comply with all study conditions
Exclusion Criteria:
* A. Contraindications to angiography and selective catheterization B. Known anaphylaxis to iodinated contrast C. Expected lung dose \> 30Gy per a session D. Unable to avoid non-target 90Y flow into the extrahepatic organs except the lungs E. Decompensated liver cirrhosis (Child-Pugh score \> 7) F. Active uncontrolled infection G. Pregnancy H. Current or history (\< or = 5 years) of malignancies in the other organs I. History of liver transplantation J. Any vascular invasion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07278102
Study Brief:
Protocol Section:
NCT07278102