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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Date data sharing statement initially provided
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
Universal Trial Number (UTN)
Trial acronym
Genesis GBM 001
Linked study record

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

Study type
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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 23526 0
2290 - Gateshead

Funding & Sponsors
Funding source category [1] 298336 0
Name [1] 298336 0
Genesis Care
Address [1] 298336 0
Building 1 and 11, The Mill
41-43 Bourke Road
Alexandria NSW 2015
Country [1] 298336 0
Primary sponsor type
Genesis Care
Building 1 and 11, The Mill
41-43 Bourke Road
Alexandria NSW 2015
Secondary sponsor category [1] 297451 0
Name [1] 297451 0
Address [1] 297451 0
Country [1] 297451 0

Ethics approval
Ethics application status
Ethics committee name [1] 299327 0
Bellberry Ethics Committee
Ethics committee address [1] 299327 0
Bellberry Limited
129 Glen Osmond Road
Eastwood South Australia 5063
Ethics committee country [1] 299327 0
Date submitted for ethics approval [1] 299327 0
Approval date [1] 299327 0
Ethics approval number [1] 299327 0

Brief summary
The purpose of this project is to measure the uptake of a new type of Positron Emission Tomography (PET) scan (using Ga68-PSMA) in relapsed glioblastoma. We would also like to examine if standard and new x-ray techniques such as PET can be used to predict the behaviour of the cancer. This will allow us to understand if this type of scan gives a clearer image of the tumour when compared to standard scanning.

Who is it for?
You may be eligible for this study if you have histologically confirmed glioblastoma

Study details
All participants will attend on two days for PET scans. The scans will take approximately 90 minutes. Participants most recent MRI scan will also be used to identify the blood brain barrier breakdown. A blood sample will be collected - approximately 30mls at baseline.
This study will help ensure the optimal targeting of anti-cancer treatment and imaging in the future.

It is hoped this study will help ensure the optimal targeting of anti-cancer treatment and imaging in the future.
Trial website
Trial related presentations / publications
Public notes

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

Country 80070 0
Phone 80070 0
+61 2 4918 4500
Fax 80070 0
+61 2 4918 4510
Email 80070 0
Contact person for public queries
Name 80071 0
Ms Vicki Sproule
Address 80071 0
Genesis Care
36 Pacific Highway,
Gateshead NSW 2290
Country 80071 0
Phone 80071 0
+61 2 4918 4500
Fax 80071 0
+61 2 4918 4510
Email 80071 0
Contact person for scientific queries
Name 80072 0
Dr Mike Fay
Address 80072 0
Genesis Care
36 Pacific Highway,
Gateshead NSW 2290

Country 80072 0
Phone 80072 0
+61 2 4918 4500
Fax 80072 0
+61 2 4918 4510
Email 80072 0

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results