- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04926376
Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC
November 15, 2023 updated by: ABK Biomedical
Investigation of Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Grafton, New Zealand
- Auckland District Health Board
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EYE90 Microspheres Treament
Radioembolization with Eye90 Microspheres
|
Y90 glass microspheres
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
6 months
|
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
|
6 months
|
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
|
6 months
|
Overall Response Rate (ORR) by mRECIST
Time Frame: 6 months
|
ORR is defined at Complete or Partial Response using local mRECIST compared to baseline
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Robert Abraham, MD, FSIR, ABK Biomedical
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2021
Primary Completion (Actual)
November 13, 2023
Study Completion (Actual)
November 13, 2023
Study Registration Dates
First Submitted
June 9, 2021
First Submitted That Met QC Criteria
June 11, 2021
First Posted (Actual)
June 15, 2021
Study Record Updates
Last Update Posted (Estimated)
November 16, 2023
Last Update Submitted That Met QC Criteria
November 15, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Liver Diseases
- Colonic Diseases
- Intestinal Diseases
- Liver Neoplasms
- Intestinal Neoplasms
- Rectal Diseases
- Carcinoma
- Carcinoma, Hepatocellular
- Colorectal Neoplasms
Other Study ID Numbers
- ABK-QA-PROT-37
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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