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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04926376
Other study ID # ABK-QA-PROT-37
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2, 2021
Est. completion date November 13, 2023

Study information

Verified date November 2023
Source ABK Biomedical
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date November 13, 2023
Est. primary completion date November 13, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Eye90 Microspheres
Y90 glass microspheres

Locations

Country Name City State
New Zealand Auckland District Health Board Grafton

Sponsors (1)

Lead Sponsor Collaborator
ABK Biomedical

Country where clinical trial is conducted

New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of toxicity Incidence of Adverse Events = Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 6 months
Primary Incidence of TESAEs Incidence of Related Treatment Emergent Serious Adverse Events (TESAEs) according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0 6 months
Primary Overall Response Rate (ORR) by RECIST 1.1 ORR is defined at Complete or Partial Response using local RECIST 1.1 compared to baseline 6 months
Primary Overall Response Rate (ORR) by mRECIST ORR is defined at Complete or Partial Response using local mRECIST compared to baseline 6 months
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