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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Singapore
National Cancer Centre Singapore
RECRUITING
Singapore
Singapore General Hospital
RECRUITING
Singapore
Time Frame
Start Date: 2023-12-21
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 22
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Singapore General Hospital
Collaborators: National Neuroscience Institute Singapore, Duke-NUS Graduate Medical School, National Cancer Centre, Singapore

This content was sourced from clinicaltrials.gov