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

Phase 2

Recruiting

• Conditions: Glioma, Malignant

• 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

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