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

Singapore General Hospital2 sites in 1 country22 target enrollmentDecember 21, 2023

ConditionsGlioma, Malignant

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Glioma, Malignant
Sponsor: Singapore General Hospital
Enrollment: 22
Locations: 2
Primary Endpoint: Performance characteristics of FET PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 21, 2023

End Date

February 28, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Singapore General Hospital

Responsible Party

Sponsor

Eligibility Criteria

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