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

NCT05953337 | Active Not Recruiting DMC FDA Device

• 1 other identifier: ABK-CA-PROT-85
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 22

Brief Summary

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Overall response rate (ORR)

  The percentage of subjects with ORR using local mRECIST, as assessed by independent panel review.

  6 months

• Duration of response (DoR)

  DoR is defined as response ≥ 6 months for ≥ 60% of responders first occurrence of CR or PR

  6 months

• Incidence of adverse events (AEs)

  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)

  Incidence of SAEs, grouped by SOC and PT, relatedness to study treatment/procedure, and severity.

  12 months

Study Arms (1)

EYE90 Microspheres Treatment

EXPERIMENTAL

Radioembolization with Eye90 Microspheres

Device: EYE90 Microspheres Treatment

Interventions

EYE90 Microspheres Treatment DEVICE

Y90 glass microspheres

EYE90 Microspheres Treatment

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ABK Biomedical: lead

Study Sites (22)

The University of Arizona Cancer Center

Tucson, Arizona, 85719, United States

Location

University of California - Irvine

Orange, California, 92867, United States

Location

AdventHealth Radiation Oncology at Altamonte Springs

Altamonte Springs, Florida, 32701, United States

Location

Miami Cardiac and Vascular Institute at Baptist Hospital Miami

Miami, Florida, 33176, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Northwestern University Memorial Hospital

Chicago, Illinois, 60611, United States

Location

University of Illinois Hospital and Health Sciences System

Chicago, Illinois, 60612, United States

Location

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Beth Israel Deaconess

Boston, Massachusetts, 02215, United States

Location

University of Missouri - Ellis Fischel Cancer Center

Columbia, Missouri, 65212, United States

Location

SSM Health Saint Louis University

St Louis, Missouri, 63104, United States

Location

Weill Cornell Medicine-New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Charlotte Radiology

Charlotte, North Carolina, 28202, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

HCA Healthcare Research Institute (Sarah Cannon)

Nashville, Tennessee, 37203, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Inland Imaging

Spokane, Washington, 99203, United States

Location

Froedtert Hospital/Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Vancouver Coastal Health Research Institution (VCHRI)

Vancouver, British Columbia, V5Z 1M9, Canada

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Liver Diseases

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases

Study Officials

• Andrew Kennedy, MD

  Director, Radiation Oncology Research at Sarah Cannon

  PRINCIPAL INVESTIGATOR

• Ammar Sarwar, MD

  Director of Radiation Oncology Research, Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

• Aravind Arepally, MD

  ABK Biomedical, Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 20, 2023
• Study Start: September 21, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (21); CA (1)