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

Sponsor

ABK Biomedical (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04926376

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Non-resectable Metastatic Colorectal Cancer Liver Cancer	Device: Eye90 Microspheres	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open LabelOpen Label

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 2, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jan 1, 2023

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: EYE90 Microspheres Treament

Radioembolization with Eye90 Microspheres

Device: Eye90 Microspheres

Y90 glass microspheres

Outcome Measures

Primary Outcome Measures

Incidence of toxicity [6 months]
Incidence of Adverse Events ≥ Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
Incidence of TESAEs [6 months]
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 [6 months]
ORR is defined at Complete or Partial Response using local RECIST 1.1 compared to baseline
Overall Response Rate (ORR) by mRECIST [6 months]
ORR is defined at Complete or Partial Response using local mRECIST compared to baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts 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.