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Trial details imported from ClinicalTrials.gov

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

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
Not applicable
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04926376

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