Using Eye90 microspheres to treat liver cancer
Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)
This study is testing whether Eye90 microspheres, which deliver targeted radiation, can help people with liver cancer that can’t be surgically removed feel better and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | ABK Biomedical Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 20 sites (Tucson, Arizona and 19 other locations) |
| Trial ID | NCT05953337 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of Eye90 microspheres, a device containing radioactive yttrium-90, for treating patients with unresectable hepatocellular carcinoma (HCC). The study is prospective, multi-center, and open-label, focusing on patients with specific criteria related to tumor size and liver function. Participants will receive treatment in a single session, targeting their liver tumors with localized radiation therapy to improve outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of unresectable hepatocellular carcinoma and specific tumor characteristics.
Not a fit: Patients with significant liver dysfunction or those with extrahepatic disease may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a new, effective option for patients with unresectable liver cancer.
How similar studies have performed: Previous studies using similar radioembolization techniques have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Tucson, Arizona and 19 other locations
- The University of Arizona Cancer Center — Tucson, Arizona, United States (Recruiting)
- University of California - Irvine — Orange, California, United States (Recruiting)
- AdventHealth Radiation Oncology at Altamonte Springs — Altamonte Springs, Florida, United States (Recruiting)
- Miami Cardiac and Vascular Institute at Baptist Hospital Miami — Miami, Florida, United States (Recruiting)
- Emory University Hospital Midtown — Atlanta, Georgia, United States (Recruiting)
- Piedmont Hospital — Atlanta, Georgia, United States (Recruiting)
- University of Illinois Hospital and Health Sciences System — Chicago, Illinois, United States (Recruiting)
- University of Iowa Health Care — Iowa City, Iowa, United States (Recruiting)
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
- Ochsner Clinic Foundation — New Orleans, Louisiana, United States (Recruiting)
- Beth Israel Deaconess — Boston, Massachusetts, United States (Recruiting)
- University of Missouri - Ellis Fischel Cancer Center — Columbia, Missouri, United States (Recruiting)
- SSM Health Saint Louis University — St. Louis, Missouri, United States (Recruiting)
- Weill Cornell Medicine-New York Presbyterian Hospital — New York, New York, United States (Recruiting)
- Charlotte Radiology — Charlotte, North Carolina, United States (Recruiting)
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- HCA Healthcare Research Institute (Sarah Cannon) — Nashville, Tennessee, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
- Inland Imaging — Spokane, Washington, United States (Recruiting)
- Froedtert Hospital/Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Principal investigator: Andrew Kennedy, MD — Director, Radiation Oncology Research at Sarah Cannon
- Study coordinator: ABK Biomedical
- Email: safety@abkbiomedical.com
- Phone: 902.442.4009
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.