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FET PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Glioma

ConditionGlioma, Malignant
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21+
SponsorSingapore General Hospital

About this trial

The goal of this clinical trial is to evaluate the performance characteristics of O-(2-\[18F\]fluoroethyl)-L-tyrosine (FET) PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging and determine the sensitivity and specificity of \[18F\]FET-PET in delineating disease. The main question\[s\] it aims to answer are:

* whether 18F-FET-PET will demonstrate high diagnostic accuracy to detect true tumour progression * whether we can optimise the threshold cut-offs for TBRmax and other relevant parameters in discriminating pseudoprogression and disease progression Participants will undergo a limited 18F-FET PET/CT of the brain in SGH.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Men or Women, aged 21 years or older at time of screening

Histologically confirmed diagnosis of malignant glioma (defined as WHO grade III or IV) with previous RT to tumour

With enlarging contrast-enhancing and/or T2W/FLAIR-hyperintense lesion(s) on MRI within the previous RT field

Gliomas with Isocitrate dehydrogenase (IDH) wild-type status, as defined on immunohistochemistry

Disqualifiers

Low-grade gliomas (histology grade 1 or 2 by WHO classification)16,17

Previous bevacizumab or other vascular endothelial growth factor (VEGF) targeting agents or anti-angiogenic treatments.

Proven cerebral metastases

IDH-mutated gliomas

Trial design

Design model

Single group

Treatments tested in this trial

  • FET PET

    Diagnostic test

    There is only one study visit during which study subjects will undergo a 18F-FET PET/CT in SGH. Following that, they will be followed up as per their routine clinical care. Data collection timepoints will be at 30 days, 4 months, 8 months and 1 year.

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: FET PETExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Performance characteristics of FET PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging

Sensitivity and specificity of \[18F\]FET-PET in delineating disease.

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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

Singapore General Hospital

Lead sponsor

National Cancer Centre, Singapore

Collaborator

National Neuroscience Institute Singapore

Collaborator

Duke-NUS Graduate Medical School

Collaborator

Source ClinicalTrials.gov
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