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

ConditionsGlioblastomaGlioblastoma Multiforme (GBM)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal North Shore Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

> 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

Disqualifiers

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

Trial population

Glioblastoma patients receiving Bevacizumab as part of standard of care.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • PSMA PET/CT scan

    Diagnostic test

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Patients with glioblastoma receiving Bevacizumab as part of their standard of care1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

Other outcomes

1

Changes in PSMA PET SUVmax before and after bevacizumab administration.

Time frame
Prior to first administration of bevacizumab to 6 weeks after.
2

Changes in PSMA PET SUVmean before and after bevacizumab administration.

Time frame
Prior to first administration of bevacizumab to 6 weeks after.
3

Changes in PSMA PET SUVpeak before and after bevacizumab administration.

Time frame
Prior to first administration of bevacizumab to 6 weeks after.

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Royal North Shore HospitalRecruiting2065, Saint Leonards, New South WalesAustraliaAustralia

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Royal North Shore Hospital

Lead sponsor

Source ClinicalTrials.gov
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