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

Phase 2

Recruiting

• Conditions: Glioma, Malignant
• Interventions: Diagnostic Test: FET PET

• Registration Number: NCT06172595
• Lead Sponsor: Singapore General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Study Start: 2023-12-21
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-28
• Last Update Posted: 2024-12-03
• Primary Completion: 2025-12-31
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
FET PET	FET PET	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore

Singapore General Hospital; 🇸🇬 Singapore, Singapore