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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04926376


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT04926376
Ethics application status
Date submitted
9/06/2021
Date registered
15/06/2021
Date last updated
18/11/2023

Titles & IDs
Public title
Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC
Scientific title
Investigation of Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)
Secondary ID [1] 0 0
ABK-QA-PROT-37
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatocellular Carcinoma Non-resectable 0 0
Metastatic Colorectal Cancer 0 0
Liver Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Eye90 Microspheres

Experimental: EYE90 Microspheres Treament - Radioembolization with Eye90 Microspheres


Treatment: Devices: Eye90 Microspheres
Y90 glass microspheres
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of toxicity
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
Incidence of TESAEs
Timepoint [2] 0 0
6 months
Primary outcome [3] 0 0
Overall Response Rate (ORR) by RECIST 1.1
Timepoint [3] 0 0
6 months
Primary outcome [4] 0 0
Overall Response Rate (ORR) by mRECIST
Timepoint [4] 0 0
6 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/11/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/11/2023
Sample size
Target
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Grafton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
ABK Biomedical
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04926376
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Abraham, MD, FSIR
Address 0 0
ABK Biomedical
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries




Additional trial details provided through ANZCTR
Accrual to date
2
Recruitment state(s)
Recruiting in New Zealand
Province(s)/district(s)
Funding & Sponsors
Primary sponsor
Commercial sector/Industry
Primary sponsor name
ABK Biomedical Inc
Primary sponsor address
Primary sponsor country
United States of America
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 44
Ministry of Health
Address [1] 44
Health and Disability Ethics Committees PO Box 5013 Wellington 6140
Country [1] 44
New Zealand
Date submitted for ethics approval [1] 44
27/08/2021
Approval date [1] 44
22/10/2021
Ethics approval number [1] 44
21/NTB/228
 
Public notes

Contacts
Principal investigator
Title 317 0
Dr
Name 317 0
Andrew Holden, MBChB FRANZCR
Address 317 0
Auckland City Hospital
Country 317 0
New Zealand
Phone 317 0
(09) 3074949 ext: 23905
Fax 317 0
Email 317 0
Contact person for public queries
Title 318 0
Dr
Name 318 0
Helen Knight
Address 318 0
Auckland City Hospital
Country 318 0
New Zealand
Phone 318 0
093074949 ext 24756
Fax 318 0
Email 318 0
Contact person for scientific queries
Title 319 0
Dr
Name 319 0
Robert Abraham, MD, FSIR
Address 319 0
ABK Biomedical Inc
Country 319 0
Canada
Phone 319 0
+1.902.442.4009
Fax 319 0
Email 319 0
safety@abkbiomedical.com