Hepatocellular Carcinoma Non-resectableNCT04926376
Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)
A study testing Eye90 Microspheres in people with Hepatocellular Carcinoma Non-resectable and Metastatic Colorectal Cancer, run by ABK Biomedical at 1 site in New Zealand.
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable, Metastatic Colorectal Cancer, Liver Cancer
- What is being tested?
- Eye90 Microspheres
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteNew Zealand
- Study dates
- 2 Nov 2021to 13 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Eye90 Microspheres
- Keywords
- Hepatocellular Carcinoma, Metastatic Colorectal Cancer, Liver Neoplasms, Liver Diseases, Internal radiation brachytherapy, Radioembolization, Y90, Yttrium-90, Eye90 microspheres
- Medical subject headings
- Colorectal Neoplasms, Liver Neoplasms, Carcinoma, Hepatocellular, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye90 MicrospheresDevice
Y90 glass microspheres
| Study group | Role | What they receive |
|---|---|---|
| EYE90 Microspheres Treament | Experimental | Radioembolization with Eye90 Microspheres Receives: Device: Eye90 Microspheres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of toxicity
Incidence of Adverse Events ≥ Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
Measured: 6 months
Incidence of TESAEs
Incidence of Related Treatment Emergent Serious Adverse Events (TESAEs) according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
Measured: 6 months
Overall Response Rate (ORR) by RECIST 1.1
ORR is defined at Complete or Partial Response using local RECIST 1.1 compared to baseline
Measured: 6 months
Overall Response Rate (ORR) by mRECIST
ORR is defined at Complete or Partial Response using local mRECIST compared to baseline
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start2 Nov 2021
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- ABK Biomedical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, ABK Biomedical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926376
- Sponsor's protocol ID
- ABK-QA-PROT-37
- Status last verified
- Nov 2024
- First submitted
- 9 Jun 2021
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)
- ClinicalTrials.gov ID
- NCT04926376
- Acronym / sponsor ID
- ABK-QA-PROT-37
- Keywords
- Hepatocellular Carcinoma, Metastatic Colorectal Cancer, Liver Neoplasms, Liver Diseases, Internal radiation brachytherapy, Radioembolization, Y90, Yttrium-90
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- ABK BiomedicalIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 15 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open Label
| Arm | Type | Receives |
|---|---|---|
| EYE90 Microspheres Treament | Experimental | Device: Eye90 MicrospheresRadioembolization with Eye90 Microspheres |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye90 MicrospheresY90 glass microspheres | Device | EYE90 Microspheres Treament |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chief Medical Officer study director
ABK Biomedical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eye90 Microspheres in people with Hepatocellular Carcinoma Non-resectable and Metastatic Colorectal Cancer, run by ABK Biomedical at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of toxicity (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.