Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)

Running, not enrolling · Not applicable

Conditions studied: Hepatocellular Carcinoma, Hepatocellular Carcinoma Non-resectable, Liver Cancer

In brief

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.

Key facts

Study ID

NCT05953337

Run by

ABK Biomedical

People needed

120

Starts

2023-09-21

Expected to finish

2027-02-01

Last updated by the study team

2026-03-04

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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.

Where it is running

• The University of Arizona Cancer Center — Tucson, Arizona, United States
• University of California - Irvine — Orange, California, United States
• AdventHealth Radiation Oncology at Altamonte Springs — Altamonte Springs, Florida, United States
• Miami Cardiac and Vascular Institute at Baptist Hospital Miami — Miami, Florida, United States
• Emory University Hospital Midtown — Atlanta, Georgia, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Northwestern University Memorial Hospital — Chicago, Illinois, United States
• University of Illinois Hospital and Health Sciences System — Chicago, Illinois, United States
• University of Iowa Health Care — Iowa City, Iowa, United States
• University of Louisville — Louisville, Kentucky, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Beth Israel Deaconess — Boston, Massachusetts, United States
• University of Missouri - Ellis Fischel Cancer Center — Columbia, Missouri, United States
• SSM Health Saint Louis University — St Louis, Missouri, United States
• Weill Cornell Medicine-New York Presbyterian Hospital — New York, New York, United States
• Charlotte Radiology — Charlotte, North Carolina, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• HCA Healthcare Research Institute (Sarah Cannon) — Nashville, Tennessee, United States
• University of Utah — Salt Lake City, Utah, United States
• Inland Imaging — Spokane, Washington, United States
• Froedtert Hospital/Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Vancouver Coastal Health Research Institution (VCHRI) — Vancouver, British Columbia, Canada

Full record on ClinicalTrials.gov

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