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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04926376
Recruitment Status : Recruiting
First Posted : June 15, 2021
Last Update Posted : January 31, 2023
Sponsor:
Information provided by (Responsible Party):
ABK Biomedical

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open 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 : November 2, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : September 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: EYE90 Microspheres Treament
Radioembolization with Eye90 Microspheres
 Device: Eye90 Microspheres
Y90 glass microspheres


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of toxicity [ Time Frame: 6 months ]
    Incidence of Adverse Events ≥ Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

  2. Incidence of TESAEs [ Time Frame: 6 months ]
    Incidence of Related Treatment Emergent Serious Adverse Events (TESAEs) according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

  3. Overall Response Rate (ORR) by RECIST 1.1 [ Time Frame: 6 months ]
    ORR is defined at Complete or Partial Response using local RECIST 1.1 compared to baseline

  4. Overall Response Rate (ORR) by mRECIST [ Time Frame: 6 months ]
    ORR is defined at Complete or Partial Response using local mRECIST compared to baseline


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04926376


Contacts
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Contact: ABK Biomedical +1.902.442.4009 safety@abkbiomedical.com

Locations
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New Zealand
Auckland District Health Board Recruiting
Grafton, New Zealand
Contact: Helen Knight         
Principal Investigator: Andrew Holden, MBChB FRANZCR         
Sponsors and Collaborators
ABK Biomedical
Investigators
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Study Director: Robert Abraham, MD, FSIR ABK Biomedical
More Information
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Responsible Party: ABK Biomedical
ClinicalTrials.gov Identifier: NCT04926376    
Other Study ID Numbers: ABK-QA-PROT-37
First Posted: June 15, 2021    Key Record Dates
Last Update Posted: January 31, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
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
Keywords provided by ABK Biomedical:
Hepatocellular Carcinoma
Metastatic Colorectal Cancer
Liver Neoplasms
Liver Diseases
Internal radiation brachytherapy
 Radioembolization
Y90
Yttrium-90
Eye90 microspheres
Additional relevant MeSH terms:
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Carcinoma
Colorectal Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adenocarcinoma
Liver Neoplasms
Liver Diseases