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

NCT04926376 | Completed FDA Device

• 1 other identifier: ABK-QA-PROT-37
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma Non-resectable; Metastatic Colorectal Cancer; Liver Cancer

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

EYE90 Microspheres Treament

EXPERIMENTAL

Radioembolization with Eye90 Microspheres

Device: Eye90 Microspheres

Interventions

Eye90 Microspheres DEVICE

Y90 glass microspheres

EYE90 Microspheres Treament

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ABK Biomedical: lead

Study Sites (1)

Auckland District Health Board

Grafton, New Zealand

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Liver Neoplasms; Carcinoma, Hepatocellular; Liver Diseases

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Chief Medical Officer

  ABK Biomedical

  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

Model Details: Open Label

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 15, 2021
• Study Start: November 2, 2021
• Primary Completion: November 13, 2023
• Study Completion: November 13, 2023
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)