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

NCT ID: NCT04926376

Last Updated: 2024-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-02
• Study Completion Date: 2023-11-13

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EYE90 Microspheres Treament

Radioembolization with Eye90 Microspheres

Group Type: EXPERIMENTAL

Eye90 Microspheres

Intervention Type: DEVICE

Y90 glass microspheres

Interventions

Eye90 Microspheres

Y90 glass microspheres

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ABK Biomedical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chief Medical Officer

Role: STUDY_DIRECTOR

ABK Biomedical

Locations

Auckland District Health Board

Grafton, , New Zealand

Countries

New Zealand

Other Identifiers

ABK-QA-PROT-37

Identifier Type: -

Identifier Source: org_study_id