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Not yet recruiting NCT07052877

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

Observational Glioblastoma Glioblastoma Multiforme (GBM)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PSMA PET/CT scan.
Who it may be relevant to
Registry conditions: Glioblastoma, Glioblastoma Multiforme (GBM). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Investigating Glioblastoma PSMA Expression by Utilizing Anti-VEGF and Its Effect on PSMA PET Scan Avidity

Overview

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.

Interventions

  • Diagnostic test PSMA PET/CT scan
    PSMA PET scan will be used to monitor changes in PSMA expression in response to bevacizumab.

Primary outcome measures

  • Changes in PSMA PET metabolic tumour volume (MTV) before and after bevacizumab administration. [Time frame: Prior to first administration of bevacizumab to 6 weeks after.]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Australia · 1 center
  • Royal North Shore Hospital — Saint Leonards

Identifiers

NCT: NCT07052877 · GUAVA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗