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Back|NCT05953337Recruiting
Official Title

Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)

Sponsor
ABK Biomedical
Enrollment
120
Timeline
Sep 2023 → Feb 2027
About This Study

This is a prospective, multi-center, open-label study to evaluate the effectiveness and safety of Eye90 microspheres® in the treatment of subjects with unresectable Hepatocellular Carcinoma (HCC). Eye90 microspheres is a medical device containing yttrium-90 (Y-90), a radioactive material, and provides local radiation brachytherapy for the treatment of liver tumors.

Eligibility Criteria

Inclusion Criteria

  • 1Must 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.
  • 2No extra hepatic disease.
  • 3Up 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.
  • 4Maximal 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.
  • 5Intent to treat all lesions within a single session.
  • 6Hypervascular on CBCT, CT, or MRI.
  • 7Evidence that \> 33% of the total liver volume is disease-free and will be spared Eye90 treatment.
  • 8Life expectancy of ≥ 6 months.
  • 9≥ 18 years old at the time of informed consent

Exclusion Criteria

  • 1Platelet count \<50,000/microliter or prothrombin (PT) activity \> 50% normal.
  • 2Hemoglobin ≤ 8.5 g/dL (subjects that are non-responders to transfusion or medical management must be excluded).
  • 3INR \> 1.7 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).
  • 4ALT \> 5x upper limit.
  • 5AST \> 5x upper limit.
  • 6Bilirubin ≥ 2.0 mg/dL.
  • 7eGFR ≤ 50 mL/min/BSA.
  • 8Macrovascular invasion.
  • 9Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater.
  • 10Estimated lung dose \> 30 Gy as calculated using the lung shunt fraction and partition model.

Locations

22 sites participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

Zachary Bercu, MD

The University of Arizona Cancer Center

Tucson, Arizona 85719

Active, Not Recruiting

University of California - Irvine

Orange, California 92867

Recruiting

Nadine Abi-Jaoudeh, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →