RECRUITING

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

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Conditions

Hepatocellular CarcinomaHepatocellular Carcinoma Non-resectableLiver CancerLiver DiseasesInternal radiation brachytherapyRadioembolizationY90Yttrium-90Eye90 microspheres

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-09-21
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05953337

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * No extra hepatic disease.
  3. * 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.
  4. * 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.
  5. * Intent to treat all lesions within a single session.
  6. * Hypervascular on CBCT, CT, or MRI.
  7. * Evidence that \> 33% of the total liver volume is disease-free and will be spared Eye90 treatment.
  8. * Life expectancy of ≥ 6 months.
  9. * ≥ 18 years old at the time of informed consent
  1. * Platelet count \<50,000/microliter or prothrombin (PT) activity \> 50% normal.
  2. * Hemoglobin ≤ 8.5 g/dL (subjects that are non-responders to transfusion or medical management must be excluded).
  3. * INR \> 1.7 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).
  4. * ALT \> 5x upper limit.
  5. * AST \> 5x upper limit.
  6. * Bilirubin ≥ 2.0 mg/dL.
  7. * eGFR ≤ 50 mL/min/BSA.
  8. * Macrovascular invasion.
  9. * Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater.
  10. * Estimated lung dose \> 30 Gy as calculated using the lung shunt fraction and partition model.

Contacts and Locations

Study Contact

ABK Biomedical
CONTACT
902.442.4009
safety@abkbiomedical.com

Principal Investigator

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 Locations (Sites)

The University of Arizona Cancer Center
Tucson, Arizona, 85719
United States
University of California - Irvine
Orange, California, 92867
United States
AdventHealth Radiation Oncology at Altamonte Springs
Altamonte Springs, Florida, 32701
United States
Piedmont Hospital
Atlanta, Georgia, 30309
United States
University of Louisville
Louisville, Kentucky, 40202
United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
United States
Beth Israel Deaconess
Boston, Massachusetts, 02215
United States
University of Missouri - Ellis Fischel Cancer Center
Columbia, Missouri, 65212
United States
SSM Health Saint Louis University
Saint Louis, Missouri, 63104
United States
Weill Cornell Medicine-New York Presbyterian Hospital
New York, New York, 10065
United States
Charlotte Radiology
Charlotte, North Carolina, 28202
United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
HCA Healthcare Research Institute (Sarah Cannon)
Nashville, Tennessee, 37203
United States
University of Utah
Salt Lake City, Utah, 84112
United States
Inland Imaging
Spokane, Washington, 99203
United States
Froedtert Hospital/Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: 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

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 Registration Dates

Study Start Date2023-09-21
Study Completion Date2025-10

Study Record Updates

Study Start Date2023-09-21
Study Completion Date2025-10

Terms related to this study

Keywords Provided by Researchers

  • Hepatocellular Carcinoma
  • Liver Cancer
  • Liver Diseases
  • Internal radiation brachytherapy
  • Radioembolization
  • Y90
  • Yttrium-90
  • Eye90 microspheres

Additional Relevant MeSH Terms

  • Hepatocellular Carcinoma
  • Hepatocellular Carcinoma Non-resectable
  • Liver Cancer