Clareo Health | Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)
Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)
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
Measurable disease defined as at least one unidimensional measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI).
Must have at least one lesion \> 2 cm within the target perfused volume.
At least one lesion must meet the definition of target lesion as defined by RECIST 1.1 or mRECIST.
Total linear length of all lesions must be ≤ 9 cm.
Must have preservation of \>700cc of normal liver parenchyma outside of treated volume.
Hypervascular lesions on CT scan with 99mTC MAA SPECT/CT T:N ratio 3:1 or higher and Hypervascular on CBCT.
No prior locoregional therapies in the liver other than previous Drug Eluting Bead TACE and/or local HCC recurrence after thermal ablation. Last TACE and/or ablation treatment must be at least 3 months prior to informed consent. Prior Lumi or Lipiodol TACE is not allowed.
Life expectancy of ≥ 6 months.
≥ 18 years old.
You may not be if
Hemoglobin ≤ 85 mg/L.
Platelet count \< 50,000/microliter or prothrombin (PT) activity \> 50% normal
INR \> 1.4 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).
ALT \> 2.5x upper limit
AST \> 2.5x upper limit
For HCC subjects, Bilirubin ≥ 2 mg/dL.
For mCRC subjects, Bilirubin ≥ 1.2 mg/dL.
eGFR ≤ 60 mL/min/1.73 m2.
Portal vein thrombosis (PVT).
Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater
Estimated lung dose \> 30 Gy as calculated using the lung shunt % and partition model.
