RecruitingPhase 2NCT06172595

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

18F-FET (O-(2-[18F]Fluoroethyl)-L-tyrosine) PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Gliomas

Sponsor

Singapore General Hospital

Enrollment

22 participants

Start Date

Dec 21, 2023

Study Type

INTERVENTIONAL

Conditions

Glioma, Malignant

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.

Eligibility

Min Age: 21 Years

Inclusion Criteria5

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 Criteria5

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

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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.