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Brachytherapy
Radioembolization with EYE90 Microspheres for Liver Cancer
N/A
Recruiting
Led By Ammar Sarwar, MD
Research Sponsored by ABK Biomedical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing Eye90 microspheres®, tiny beads with radioactive material, on patients with liver cancer that can't be removed by surgery. The beads deliver radiation directly to the tumor to kill cancer cells. Yttrium-90 microspheres have been increasingly used for treating liver cancers that cannot be surgically removed by delivering high doses of radiation directly to tumors.
Who is the study for?
This trial is for adults with unresectable Hepatocellular Carcinoma (HCC) who have a single liver tumor ≤ 8 cm or multiple tumors with a combined size of ≤ 12 cm. Participants must have at least one measurable lesion, no extra hepatic disease, and a life expectancy of over 6 months. They cannot join if they have severe kidney issues, blood disorders, compromised biliary systems, or are at risk for high radiation exposure to the lungs.
What is being tested?
The study tests Eye90 microspheres®, which deliver targeted radiation directly to liver tumors using yttrium-90 (Y-90). The goal is to treat all lesions in one session and evaluate the effectiveness and safety of this local brachytherapy approach in patients with HCC.
What are the potential side effects?
Potential side effects may include localized pain, nausea, fatigue due to radiation exposure; there's also a risk of damage to surrounding healthy liver tissue or other nearby organs from the radioactive material.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Duration of response (DoR)
Incidence of adverse events (AEs)
Incidence of serious adverse events (SAEs)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: EYE90 Microspheres TreatmentExperimental Treatment1 Intervention
Radioembolization with Eye90 Microspheres
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Localized radiation therapy using Yttrium-90 (Y-90) microspheres, such as Eye90 microspheres®, involves injecting radioactive particles directly into the liver's blood supply. These particles emit radiation that targets and destroys cancer cells while sparing surrounding healthy tissue.
This method is particularly beneficial for liver cancer patients as it provides a focused treatment with minimal systemic side effects. Other common treatments include transarterial chemoembolization (TACE), which combines chemotherapy with embolization to block the tumor's blood supply, and external beam radiation therapy (EBRT), which uses high-energy beams to target cancer cells.
These treatments are crucial as they offer options for patients who are not candidates for surgery, aiming to control tumor growth and improve survival rates.
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Who is running the clinical trial?
ABK BiomedicalLead Sponsor
1 Previous Clinical Trials
8 Total Patients Enrolled
1 Trials studying Liver Cancer
8 Patients Enrolled for Liver Cancer
Ammar Sarwar, MDPrincipal InvestigatorDirector of Radiation Oncology Research, Beth Israel Deaconess Medical Center
1 Previous Clinical Trials
137 Total Patients Enrolled
Andrew Kennedy, MDPrincipal InvestigatorDirector, Radiation Oncology Research at Sarah Cannon
1 Previous Clinical Trials
26 Total Patients Enrolled
Aravind Arepally, MDStudy DirectorABK Biomedical, Inc