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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07052877




Registration number
NCT07052877
Ethics application status
Date submitted
23/06/2025
Date registered
7/07/2025
Date last updated
11/07/2025

Titles & IDs
Public title
The Effect of Glioblastoma PSMA Expression Following Tumour VEGF Blockade From Bevacizumab
Scientific title
Investigating Glioblastoma PSMA Expression by Utilizing Anti-VEGF and Its Effect on PSMA PET Scan Avidity
Secondary ID [1] 0 0
GUAVA
Universal Trial Number (UTN)
Trial acronym
GUAVA
Linked study record

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

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Diagnosis / Prognosis - PSMA PET/CT scan

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


Diagnosis / Prognosis: PSMA PET/CT scan
PSMA PET scan will be used to monitor changes in PSMA expression in response to bevacizumab.
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in PSMA PET metabolic tumour volume (MTV) before and after bevacizumab administration.
Timepoint [1] 0 0
Prior to first administration of bevacizumab to 6 weeks after.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/07/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - Saint Leonards
Recruitment postcode(s) [1] 0 0
2065 - Saint Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Alexander Yuile
Address 0 0
Country 0 0
Phone 0 0
+61 2 94631171
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07052877