Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular C… (NCT04926376) | Clinical Trial Compass
CompletedNot Applicable
Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)
New Zealand8 participantsStarted 2021-11-02
Plain-language summary
The purpose of this study is to evaluate the safety of treatment with Eye90 microspheres in patients with unresectable Hepatocellular Carcinoma (HCC) and metastatic Colorectal Cancer (mCRC). Both cause tumors, known as malignant hyper-vascular hepatic neoplasia, that have an abnormally large number of blood vessels attached to them. Eye90 is internal radiation brachytherapy for treatment of malignant hyper-vascular hepatic neoplasia that uses microspheres, tiny glass beads smaller in diameter than a human hair, to provide radiation. The microspheres contain Yttrium-90 (Y90) as the radiation source, which are used to to kill cancer cells and shrink tumors. The microspheres are also radiopaque, which means that they can be seen during imaging procedures. The visibility of the microspheres allows the study doctor to confirm the microspheres have been delivered in the tumor; this may help to improve the outcome of treatment.
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:
* Measurable disease defined as at least one unidimensional measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI).
* Must have at least one lesion \> 2 cm within the target perfused volume.
* At least one lesion must meet the definition of target lesion as defined by RECIST 1.1 or mRECIST.
* Total linear length of all lesions must be ≤ 9 cm.
* Must have preservation of \>700cc of normal liver parenchyma outside of treated volume.
* Hypervascular lesions on CT scan with 99mTC MAA SPECT/CT T:N ratio 3:1 or higher and Hypervascular on CBCT.
* No prior locoregional therapies in the liver other than previous Drug Eluting Bead TACE and/or local HCC recurrence after thermal ablation. Last TACE and/or ablation treatment must be at least 3 months prior to informed consent. Prior Lumi or Lipiodol TACE is not allowed.
* Life expectancy of ≥ 6 months.
* ≥ 18 years old.
Exclusion Criteria:
* Hemoglobin ≤ 85 mg/L.
* Platelet count \< 50,000/microliter or prothrombin (PT) activity \> 50% normal
* INR \> 1.4 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).
* ALT \> 2.5x upper limit
* AST \> 2.5x upper limit
* For HCC subjects, Bilirubin ≥ 2 mg/dL.
* For mCRC subjects, Bilirubin ≥ 1.2 mg/dL.
* eGFR ≤ 60 mL/min/1.73 m2.
* Portal vein thrombosis (PVT).
* Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater
* Estimated lung dose \> 30 Gy as calculated using the lung sh…
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.