Glioma, Malignant
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTFET PET
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.
Sponsors
National Cancer Centre, Singapore
National Neuroscience Institute Singapore
Duke-NUS Graduate Medical School
Singapore General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Subject must consent to undergo all study procedures
Exclusion criteria
* 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 * Pregnancy/ breast-feeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Performance characteristics of FET PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging | 1 year | Sensitivity and specificity of \[18F\]FET-PET in delineating disease. |
Countries
Singapore
Outcome results
None listed