Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ABK Biomedical
Age
18–99
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must have a confirmed diagnosis of HCC by imaging confirmation with Liver Imaging Reporting and Data System (LIRADS) category 5 or confirmation of HCC via biopsy.
No extra hepatic disease.
Up to 3 lesions with at least one lesion ≥ 2 cm in diameter (long axis) measurable by computed tomography (CT), CBCT, or MRI. At least one lesion must be identified as a target lesion as defined by mRECIST.
Maximal single lesion size of ≤ 8 cm and sum of the maximal tumor dimensions of ≤ 12 cm with the entire tumor burden expected to be treatable within the perfused volume.
Intent to treat all lesions within a single session.
Hypervascular on CBCT, CT, or MRI.
Evidence that \> 33% of the total liver volume is disease-free and will be spared Eye90 treatment.
Life expectancy of ≥ 6 months.
≥ 18 years old at the time of informed consent
You may not be if
Platelet count \<50,000/microliter or prothrombin (PT) activity \> 50% normal.
Hemoglobin ≤ 8.5 g/dL (subjects that are non-responders to transfusion or medical management must be excluded).
INR \> 1.7 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).
ALT \> 5x upper limit.
AST \> 5x upper limit.
Bilirubin ≥ 2.0 mg/dL.
eGFR ≤ 50 mL/min/BSA.
Macrovascular invasion.
Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater.
Estimated lung dose \> 30 Gy as calculated using the lung shunt fraction and partition model.
