Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC
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|ClinicalTrials.gov Identifier: NCT04926376|
Recruitment Status : Recruiting
First Posted : June 15, 2021
Last Update Posted : January 31, 2023
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|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma Non-resectable Metastatic Colorectal Cancer Liver Cancer||Device: Eye90 Microspheres||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open Label|
|Masking:||None (Open Label)|
|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|
Experimental: EYE90 Microspheres Treament
Radioembolization with Eye90 Microspheres
Device: Eye90 Microspheres
Y90 glass microspheres
- 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
- 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
- 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
- Overall Response Rate (ORR) by mRECIST [ Time Frame: 6 months ]ORR is defined at Complete or Partial Response using local mRECIST compared to baseline
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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|
- 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.
- 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.
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
|Contact: ABK Biomedicalemail@example.com|
|Auckland District Health Board||Recruiting|
|Grafton, New Zealand|
|Contact: Helen Knight|
|Principal Investigator: Andrew Holden, MBChB FRANZCR|
|Study Director:||Robert Abraham, MD, FSIR||ABK Biomedical|
|Responsible Party:||ABK Biomedical|
|Other Study ID Numbers:||
|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|
|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|
Metastatic Colorectal Cancer
Internal radiation brachytherapy
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases