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

March 2, 2026 updated by: ABK Biomedical

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver Coastal Health Research Institution (VCHRI)
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • The University of Arizona Cancer Center
    • California
      • Orange, California, United States, 92867
        • University of California - Irvine
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • AdventHealth Radiation Oncology at Altamonte Springs
      • Miami, Florida, United States, 33176
        • Miami Cardiac and Vascular Institute at Baptist Hospital Miami
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois Hospital and Health Sciences System
      • Chicago, Illinois, United States, 60611
        • Northwestern University Memorial Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Health Care
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri - Ellis Fischel Cancer Center
      • St Louis, Missouri, United States, 63104
        • SSM Health Saint Louis University
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medicine-New York Presbyterian Hospital
    • North Carolina
      • Charlotte, North Carolina, United States, 28202
        • Charlotte Radiology
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • HCA Healthcare Research Institute (Sarah Cannon)
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah
    • Washington
      • Spokane, Washington, United States, 99203
        • Inland Imaging
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital/Medical College of Wisconsin

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: EYE90 Microspheres Treatment
Radioembolization with Eye90 Microspheres
Device: EYE90 Microspheres Treatment
Y90 glass microspheres

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: 6 months
The percentage of subjects with ORR using local mRECIST, as assessed by independent panel review.
6 months
Duration of response (DoR)
Time Frame: 6 months
DoR is defined as response ≥ 6 months for ≥ 60% of responders first occurrence of CR or PR
6 months
Incidence of adverse events (AEs)
Time Frame: 12 months
Incidence of AEs, grouped by System Organ Class (SOC) and Preferred Term (PT), relatedness to study treatment/procedure, and severity.
12 months
Incidence of serious adverse events (SAEs)
Time Frame: 12 months
Incidence of SAEs, grouped by SOC and PT, relatedness to study treatment/procedure, and severity.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ABK Biomedical

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrew Kennedy, MD, Director, Radiation Oncology Research at Sarah Cannon
  • Study Director: Aravind Arepally, MD, ABK Biomedical, Inc
  • Principal Investigator: Ammar Sarwar, MD, Director of Radiation Oncology Research, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ABK-CA-PROT-85

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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