Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001346268
Ethics application status
Approved
Date submitted
11/01/2018
Date registered
9/08/2018
Date last updated
10/06/2022
Date data sharing statement initially provided
17/07/2019
Date results provided
10/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Genesis GBM 001 Phase I/II study of 68Ga-PSMA as a tumour targeting agent in relapsed glioblastoma
Scientific title
Genesis GBM 001 Phase I/II study of 68Ga-PSMA as a tumour targeting agent in relapsed glioblastoma
Secondary ID [1] 293719 0
none
Universal Trial Number (UTN)
Trial acronym
Genesis GBM 001
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
Brain Cancer
Glioblastoma 306067 0
Condition category
Condition code
Cancer 305204 305204 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot project aims to explore the extent to which 68Ga-PSMA binds to all regions within a glioma including regions of infiltration and necrosis. The extent of the tumour will be established using 18FET PET imaging. 18FET is well suited to this purpose as it is known to be taken up by amino acid transporters and has enhanced uptake in tumour regions.
Participants will be required to have 2 scans on different days. Each scan will take approximately 2 hours. These examinations will be completed on separate days within a two-week period.
The PET imaging will be performed in the imaging department by qualified Nuclear Medicine Specialists.
[F-18]FET (molecular wt. 226.23 for [F-18]FET), [mol. wt. 227.23 for [F-19]FET] is a derivative of the amino acid, tyrosine. It is a radiolabelled imaging agent that has been proposed for investigating brain tumours and gliomas with positron emission tomography (PET).
68Gallium PSMA involves an intravenous injection of a radioactive substance (68Gallium) that is chemically bound to a peptide known as PSMA (DKFZ-PSMA-11).
Intervention code [1] 299972 0
Diagnosis / Prognosis
Comparator / control treatment
There is no comparator or control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304366 0
To determine the uptake in relapsed glioblastoma of Ga-68 PSMA on PET scans.
This will be done by quantitatively measuring the tumour volume and PSMA receptor activity, FET and PMSA tracer concentrations will be normalized to the injected dose per kilogram of patient’s body weight to generate standardized uptake values (SUVs). The tumour volume will be manually defined by an experienced PET physician from the FET images.
This is not separate primary outcomes.
Timepoint [1] 304366 0
12 months post accrual of cohort.
Secondary outcome [1] 349971 0
To investigate the feasibility of undertaking PET theranostic research.
This analysis will determine whether a clinical trial using a therapeutic dose of 177Lu-PSMA would be feasible for these patients.
The decision to go on to a therapy study will depend on the standard uptake value (SUV) of PSMA PET. If this is high (great than 3) its likely that this will be feasible.
The percentage of patients showing uptake would also impact on feasibility.
Timepoint [1] 349971 0
Within 12 months of patient recruitment completetion

Eligibility
Key inclusion criteria
• Previously histologically confirmed glioblastoma at resection
• Progression noted on pre-enrolment MRI scan
• Aged 18 years or older
• An ECOG performance status score of 2 or less (see appendices)
• Participants capable of childbearing are using adequate contraception
• Available for scanning on 2 separate days
• Has provided written Informed Consent for participation in this trial once eligibility is meet
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Women who are pregnant or lactating.
• Geographically remote from the treating centre which would not allow multiple presentation for imaging

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
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
Bio-availability
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
13/08/2018
Actual
22/10/2018
Date of last participant enrolment
Anticipated
22/10/2019
Actual
9/09/2021
Date of last data collection
Anticipated
19/02/2020
Actual
13/09/2021
Sample size
Target
12
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 23526 0
2290 - Gateshead

Funding & Sponsors
Funding source category [1] 298336 0
Other
Name [1] 298336 0
Genesis Care
Country [1] 298336 0
Australia
Primary sponsor type
Other
Name
Genesis Care
Address
Building 1 and 11, The Mill
41-43 Bourke Road
Alexandria NSW 2015
Country
Australia
Secondary sponsor category [1] 297451 0
None
Name [1] 297451 0
Address [1] 297451 0
Country [1] 297451 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299327 0
Bellberry Ethics Committee
Ethics committee address [1] 299327 0
Ethics committee country [1] 299327 0
Australia
Date submitted for ethics approval [1] 299327 0
17/01/2018
Approval date [1] 299327 0
02/08/2018
Ethics approval number [1] 299327 0
2017-11-885

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 80070 0
Dr Mike Fay
Address 80070 0
Genesis Care
36 Pacific Highway,
Gateshead NSW 2290

Country 80070 0
Australia
Phone 80070 0
+61 2 4918 4500
Fax 80070 0
+61 2 4918 4510
Email 80070 0
mike.fay@genesiscare.com
Contact person for public queries
Name 80071 0
Vicki Sproule
Address 80071 0
Genesis Care
36 Pacific Highway,
Gateshead NSW 2290
Country 80071 0
Australia
Phone 80071 0
+61 2 4918 4500
Fax 80071 0
+61 2 4918 4510
Email 80071 0
vicki.sproule@genesiscare.com
Contact person for scientific queries
Name 80072 0
Mike Fay
Address 80072 0
Genesis Care
36 Pacific Highway,
Gateshead NSW 2290

Country 80072 0
Australia
Phone 80072 0
+61 2 4918 4500
Fax 80072 0
+61 2 4918 4510
Email 80072 0
mike.fay@genesiscare.com

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA novel semiautomated method for background activity and biological tumour volume definition to improve standardisation of 18F-FET PET imaging in glioblastoma.2022https://dx.doi.org/10.1186/s40658-022-00438-2
EmbaseComparison between [68Ga]Ga-PSMA-617 and [18F]FET PET as Imaging Biomarkers in Adult Recurrent Glioblastoma.2023https://dx.doi.org/10.3390/ijms242216208
N.B. These documents automatically identified may not have been verified by the study sponsor.