FET PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Glioma (FET PET in HGG)

Singapore Health Services (SingHealth)

Status and phase: Enrolling; Phase 2

Conditions: Glioma, Malignant

Treatments: Diagnostic Test: FET PET

Study type: Interventional

Funder types: Other

Identifiers

NCT06172595

202112-00050

Details and patient eligibility

About

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.

Enrollment: 22 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

FET PET

Experimental group

Description:

Upon recruitment, a single study visit will be scheduled where subjects undergo a limited 18F-FET PET/CT of the brain in SGH. After the study visit, from time of recruitment, they will continue their regular clinic visits as clinically indicated, where they will be monitored for at least a year for stability or deterioration. If clinically indicated, they may undergo conventional MRI, alternative MRI imaging and/or histopathological correlation in their respective primary institutions. During these follow-up visits, any adverse effects possibly attributed to the 18F-FET PET/CT can also be flagged up. Any alternative MRI imaging performed (as part of clinical practice in the respective primary institutions) within 4 weeks of the 18F-FET PET/CT study will also be included in the comparative analysis.

Treatment:

Diagnostic Test: FET PET