Summary

Eligibility
for people ages 18-99 (full criteria)
Location
at Orange, California and other locations
Dates
study started
completion around
Principal Investigator
by Nadine Abi-Jaoudeh, MD

Description

Summary

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.

Official Title

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

Keywords

Hepatocellular Carcinoma, Hepatocellular Carcinoma Non-resectable, Liver Cancer, Liver Diseases, Internal radiation brachytherapy, Radioembolization, Y90, Yttrium-90, Eye90 microspheres, Carcinoma, Liver Neoplasms, EYE90 Microspheres Treatment

Eligibility

You can join if…

Open to people ages 18-99

  • 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 CAN'T join 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.

Locations

  • University of California - Irvine accepting new patients
    Orange California 92867 United States
  • University of Utah accepting new patients
    Salt Lake City Utah 84112 United States

Lead Scientist at UC Irvine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ABK Biomedical
ID
NCT05953337
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated