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

November 6, 2024 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • 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 Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85719
        • Recruiting
        • The University of Arizona Cancer Center
        • Contact:
          • Study Coordinator
        • Principal Investigator:
          • Shamar Young, MD
    • California
      • Orange, California, United States, 92867
        • Recruiting
        • University of California - Irvine
        • Contact:
          • Study Coordinator
        • Principal Investigator:
          • Nadine Abi-Jaoudeh, MD
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Recruiting
        • AdventHealth Radiation Oncology at Altamonte Springs
        • Contact:
          • Study Coordinator
        • Principal Investigator:
          • Ravi Shridhar, MD
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Hospital
        • Contact:
          • Study Coordinator
        • Principal Investigator:
          • Rahul Maheshwari, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • University of Louisville
        • Contact:
          • Study Coordinator
        • Principal Investigator:
          • Robert Martin, MD
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • Ochsner Clinic Foundation
        • Contact:
          • Study Coordinator, MD
        • Principal Investigator:
          • Juan Gimenez, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess
        • Principal Investigator:
          • Ammar Sarwar, MD
        • Contact:
          • Study Coordinator
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri - Ellis Fischel Cancer Center
        • Contact:
          • Study Coordinator
        • Principal Investigator:
          • Ryan Davis, MD
      • Saint Louis, Missouri, United States, 63104
        • Recruiting
        • SSM Health Saint Louis University
        • Contact:
          • Study Coordinator
        • Principal Investigator:
          • Kirubahara Vaheesan, MD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Weill Cornell Medicine-New York Presbyterian Hospital
        • Contact:
          • Study Coordinator
        • Principal Investigator:
          • Adam Talenfeld, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28202
        • Recruiting
        • Charlotte Radiology
        • Principal Investigator:
          • Eric Wang, MD
        • Contact:
          • Study Coordinator
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Hospital of the University of Pennsylvania
        • Principal Investigator:
          • Gregory Nadolski, MD
        • Contact:
          • Study Coordinator
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • HCA Healthcare Research Institute (Sarah Cannon)
        • Contact:
          • Study Coordinator
        • Principal Investigator:
          • Andrew Kennedy, MD
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah
        • Contact:
          • Study Coordinator
        • Principal Investigator:
          • Ziga Cizman, MD
    • Washington
      • Spokane, Washington, United States, 99203
        • Recruiting
        • Inland Imaging
        • Contact:
          • Study Coordinator
        • Principal Investigator:
          • Jayson Brower, MD
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Froedtert Hospital/Medical College of Wisconsin
        • Contact:
          • Study Coordinator
        • Principal Investigator:
          • William Rilling, MD

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

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
Intervention / Treatment
Experimental: EYE90 Microspheres Treatment
Radioembolization with Eye90 Microspheres
Device: EYE90 Microspheres Treatment
Y90 glass microspheres

What is the study measuring?

Primary Outcome Measures

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

ABK Biomedical

Investigators

  • 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)

September 21, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

July 12, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 6, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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

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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