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

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.

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Key information

Conditions

Glioma, Malignant Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Centre Singapore, Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

Time frame: 1 year

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

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

Duke-NUS Graduate Medical School
National Cancer Centre, Singapore
National Neuroscience Institute Singapore

Registry information

Official study title

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

Acronym: FET PET in HGG

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2026
First posted: Dec 15, 2023
Registry last updated: Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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