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Clinical Trials in Canada / NCT05953337
Active, not recruiting Not applicable

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

NCT05953337 · tracked via the Priya Life Science Canada tracker
Sponsor
ABK Biomedical
Phase
Not applicable
Started
2023-09-21
Last updated
2026-03-04

Condition(s) studied

Hepatocellular CarcinomaHepatocellular Carcinoma Non-resectableLiver Cancer

Investigational drug(s) / intervention(s)

EYE90 Microspheres Treatment

EYE90 Microspheres Treatment: Y90 glass microspheres

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
99 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (22)

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05953337 on ClinicalTrials.gov ↗ ← All trials in Canada