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Genesis GBM 001 Phase I/II study of 68Ga-PSMA as a tumour targeting agent in relapsed glioblastoma

Genesis GBM 001 Phase I/II study of 68Ga-PSMA as a tumour targeting agent in relapsed glioblastoma

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001346268
Acronym
Genesis GBM 001
Enrollment
11
Registered
2018-08-09
Start date
2018-10-22
Completion date
2021-09-09
Last updated
2022-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 complete

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).

Sponsors

Genesis Care
Lead SponsorOther

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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

Exclusion criteria

• Women who are pregnant or lactating. • Geographically remote from the treating centre which would not allow multiple presentation for imaging

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 13, 2026