Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)
- Conditions
- Hepatocellular CarcinomaHepatocellular Carcinoma Non-resectableLiver Cancer
- Interventions
- Device: EYE90 Microspheres Treatment
- Registration Number
- NCT05953337
- Lead Sponsor
- ABK Biomedical
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description EYE90 Microspheres Treatment EYE90 Microspheres Treatment Radioembolization with Eye90 Microspheres
- Primary Outcome Measures
Name Time Method Incidence of serious adverse events (SAEs) 12 months Incidence of SAEs, grouped by SOC and PT, relatedness to study treatment/procedure, and severity.
Duration of response (DoR) 6 months DoR is defined as response ≥ 6 months for ≥ 60% of responders first occurrence of CR or PR
Overall response rate (ORR) 6 months The percentage of subjects with ORR using local mRECIST, as assessed by independent panel review.
Incidence of adverse events (AEs) 12 months Incidence of AEs, grouped by System Organ Class (SOC) and Preferred Term (PT), relatedness to study treatment/procedure, and severity.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (20)
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
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