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Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC

Primary Purpose

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

Status

Active

Phase

Not Applicable

Locations

New Zealand

Study Type

Interventional

Intervention

Eye90 Microspheres

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma Non-resectable focused on measuring Hepatocellular Carcinoma, Metastatic Colorectal Cancer, Liver Neoplasms, Liver Diseases, Internal radiation brachytherapy, Radioembolization, Y90, Yttrium-90, Eye90 microspheres

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Auckland District Health Board

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EYE90 Microspheres Treament

Arm Description

Radioembolization with Eye90 Microspheres

Outcomes

Primary Outcome Measures

Incidence of toxicity

Incidence of Adverse Events ≥ Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

Incidence of TESAEs

Incidence of Related Treatment Emergent Serious Adverse Events (TESAEs) according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

Overall Response Rate (ORR) by RECIST 1.1

ORR is defined at Complete or Partial Response using local RECIST 1.1 compared to baseline

Overall Response Rate (ORR) by mRECIST

ORR is defined at Complete or Partial Response using local mRECIST compared to baseline

Secondary Outcome Measures

Full Information

NCT ID

NCT04926376

First Posted

June 9, 2021

Last Updated

July 7, 2023

Sponsor

ABK Biomedical

1. Study Identification

Unique Protocol Identification Number

NCT04926376

Brief Title

Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 2, 2021 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ABK Biomedical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Open Label

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

EYE90 Microspheres Treament

Arm Type

Experimental

Arm Description

Radioembolization with Eye90 Microspheres

Intervention Type

Device

Intervention Name(s)

Eye90 Microspheres

Intervention Description

Y90 glass microspheres

Primary Outcome Measure Information:

Title

Incidence of toxicity

Description

Incidence of Adverse Events ≥ Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

Time Frame

6 months

Title

Incidence of TESAEs

Description

Incidence of Related Treatment Emergent Serious Adverse Events (TESAEs) according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

Time Frame

6 months

Title

Overall Response Rate (ORR) by RECIST 1.1

Description

ORR is defined at Complete or Partial Response using local RECIST 1.1 compared to baseline

Time Frame

6 months

Title

Overall Response Rate (ORR) by mRECIST

Description

ORR is defined at Complete or Partial Response using local mRECIST compared to baseline

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert Abraham, MD, FSIR

Organizational Affiliation

ABK Biomedical

Official's Role

Study Director

Facility Information:

Facility Name

Auckland District Health Board

City

Grafton

Country

New Zealand

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC

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