The Effect of Glioblastoma PSMA Expression Following Tumour VEGF Blockade From Bevacizumab

Study Purpose

This trial is a single arm study for patients receiving bevacizumab for IDH-wildtype glioblastoma. Patients receiving bevacizumab (an anti-VEGF therapy) will receive PSMA scans to investigate the role of PSMA expression in glioblastoma and its relationship to VEGF expression.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- > 18 year of age.

- ECOG 0-2.

- Able to provide informed consent for the study.

- Minimum of 1 month from completion of radiotherapy with clinical or radiography evidence suggesting residual tumour.

- Confirmed glioblastoma IDH1/2 wildtype (WHO2021) - For bevacizumab treatment as per treating physician.

- Able to comply with trial requirements.

Exclusion Criteria:

- No major organ impairment that would likely lead to unacceptable toxicities- eg significant cardiac, hepatic, renal or haematologic dysfunction (based on clinician assessment) - Any contraindication to bevacizumab, MRI gadolinium contrast or 68Ga-PSMA-617 radioisotope.

- Any implant, foreign body, 3T MRI incompatible device or other contraindication to MRI imaging.

- Does not fulfill PBS requirements for bevacizumab.

- Women lactating, pregnant or of child baring potential who are not willing to avoid pregnancy during the study

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07052877
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Royal North Shore Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	Australia
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioblastoma, Glioblastoma Multiforme (GBM)

Arms & Interventions

Arms

: Patients with glioblastoma receiving Bevacizumab as part of their standard of care

Interventions

Diagnostic Test: - PSMA PET/CT scan

PSMA PET scan will be used to monitor changes in PSMA expression in response to bevacizumab.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Royal North Shore Hospital, Saint Leonards, New South Wales 2155400, Australia

Status

Address

Royal North Shore Hospital

Saint Leonards, New South Wales 2155400, 2065

Site Contact

Alexander Yuile

[email protected]

+61 2 94631171

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