FET PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Glioma
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: FET PET.
- Who it may be relevant to
- Registry conditions: Glioma, Malignant. Basic parameters: from 21 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
- Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
18F-FET (O-(2-[18F]Fluoroethyl)-L-tyrosine) PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Gliomas
Overview
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 test FET 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.
Primary outcome measures
- Performance characteristics of FET PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Singapore · 2 centers
- National Cancer Centre Singapore — Singapore
- Singapore General Hospital — Singapore
Identifiers
NCT: NCT06172595 · 202112-00050