Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcino… (NCT05953337) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)
United States, Canada120 participantsStarted 2023-09-21
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 mod…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.