Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)

Investigation of Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)

The purpose of this study is to evaluate the safety of treatment with Eye90 microspheres in patients with unresectable Hepatocellular Carcinoma (HCC) and metastatic Colorectal Cancer (mCRC). Both cause tumors, known as malignant hyper-vascular hepatic neoplasia, that have an abnormally large number of blood vessels attached to them. Eye90 is internal radiation brachytherapy for treatment of malignant hyper-vascular hepatic neoplasia that uses microspheres, tiny glass beads smaller in diameter than a human hair, to provide radiation. The microspheres contain Yttrium-90 (Y90) as the radiation source, which are used to to kill cancer cells and shrink tumors. The microspheres are also radiopaque, which means that they can be seen during imaging procedures. The visibility of the microspheres allows the study doctor to confirm the microspheres have been delivered in the tumor; this may help to improve the outcome of treatment.

Study Overview

• Status: Completed
• Conditions: Metastatic Colorectal Cancer; Liver Cancer; Hepatocellular Carcinoma Non-resectable
• Intervention / Treatment: Device: Eye90 Microspheres

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Grafton, New Zealand
    • Auckland District Health Board

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Measurable disease defined as at least one unidimensional measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI).
• Must have at least one lesion > 2 cm within the target perfused volume.
• At least one lesion must meet the definition of target lesion as defined by RECIST 1.1 or mRECIST.
• Total linear length of all lesions must be ≤ 9 cm.
• Must have preservation of >700cc of normal liver parenchyma outside of treated volume.
• Hypervascular lesions on CT scan with 99mTC MAA SPECT/CT T:N ratio 3:1 or higher and Hypervascular on CBCT.
• No prior locoregional therapies in the liver other than previous Drug Eluting Bead TACE and/or local HCC recurrence after thermal ablation. Last TACE and/or ablation treatment must be at least 3 months prior to informed consent. Prior Lumi or Lipiodol TACE is not allowed.
• Life expectancy of ≥ 6 months.
• ≥ 18 years old.

Exclusion Criteria:

• Hemoglobin ≤ 85 mg/L.
• Platelet count < 50,000/microliter or prothrombin (PT) activity > 50% normal
• INR > 1.4 (if anticoagulated, reversal must be achieved prior to any angiographic procedures).
• ALT > 2.5x upper limit
• AST > 2.5x upper limit
• For HCC subjects, Bilirubin ≥ 2 mg/dL.
• For mCRC subjects, Bilirubin ≥ 1.2 mg/dL.
• eGFR ≤ 60 mL/min/1.73 m2.
• Portal vein thrombosis (PVT).
• Incompetent biliary duct system, prior biliary intervention, or a compromised Ampulla of Vater
• Estimated lung dose > 30 Gy as calculated using the lung shunt % and partition model.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EYE90 Microspheres Treament; Radioembolization with Eye90 Microspheres	Device: Eye90 Microspheres; Y90 glass microspheres

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of toxicity	Incidence of Adverse Events ≥ Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0	6 months
Incidence of TESAEs	Incidence of Related Treatment Emergent Serious Adverse Events (TESAEs) according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0	6 months
Overall Response Rate (ORR) by RECIST 1.1	ORR is defined at Complete or Partial Response using local RECIST 1.1 compared to baseline	6 months
Overall Response Rate (ORR) by mRECIST	ORR is defined at Complete or Partial Response using local mRECIST compared to baseline	6 months

Collaborators and Investigators

• Sponsor: ABK Biomedical
• Investigators: Study Director: Chief Medical Officer, ABK Biomedical

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2021
• Primary Completion (Actual): November 13, 2023
• Study Completion (Actual): November 13, 2023

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Hepatocellular Carcinoma; Liver Diseases; Liver Neoplasms; Metastatic Colorectal Cancer; Radioembolization; Yttrium-90; Y90; Internal radiation brachytherapy; Eye90 microspheres
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Colonic Diseases; Carcinoma; Carcinoma, Hepatocellular; Colorectal Neoplasms
• Other Study ID Numbers: ABK-QA-PROT-37

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.: Yes