Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)

Description

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.

Conditions

Hepatocellular Carcinoma, Hepatocellular Carcinoma Non-resectable, Liver Cancer

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)

Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)

Condition
Hepatocellular Carcinoma
Intervention / Treatment

-

Contacts and Locations

Tucson

The University of Arizona Cancer Center, Tucson, Arizona, United States, 85719

Orange

University of California - Irvine, Orange, California, United States, 92867

Altamonte Springs

AdventHealth Radiation Oncology at Altamonte Springs, Altamonte Springs, Florida, United States, 32701

Atlanta

Piedmont Hospital, Atlanta, Georgia, United States, 30309

Louisville

University of Louisville, Louisville, Kentucky, United States, 40202

New Orleans

Ochsner Clinic Foundation, New Orleans, Louisiana, United States, 70121

Boston

Beth Israel Deaconess, Boston, Massachusetts, United States, 02215

Columbia

University of Missouri - Ellis Fischel Cancer Center, Columbia, Missouri, United States, 65212

Saint Louis

SSM Health Saint Louis University, Saint Louis, Missouri, United States, 63104

New York

Weill Cornell Medicine-New York Presbyterian Hospital, New York, New York, United States, 10065

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ABK Biomedical,

Andrew Kennedy, MD, PRINCIPAL_INVESTIGATOR, Director, Radiation Oncology Research at Sarah Cannon

Ammar Sarwar, MD, PRINCIPAL_INVESTIGATOR, Director of Radiation Oncology Research, Beth Israel Deaconess Medical Center

Aravind Arepally, MD, STUDY_DIRECTOR, ABK Biomedical, Inc

Study Record Dates

2025-10