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

Glioma, Malignant Clinical Trial

— FET PET in HGG  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06172595
• Other study ID #: 202112-00050
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: December 21, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: December 2023
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 22
• Est. completion date: February 28, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glioma
• Glioma, Malignant

Intervention

Diagnostic Test:
• FET PET
There is only one study visit during which study subjects will undergo a 18F-FET PET/CT in SGH. Following that, they will be followed up as per their routine clinical care. Data collection timepoints will be at 30 days, 4 months, 8 months and 1 year.

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Singapore General Hospital	Duke-NUS Centre of Quantitative Medicine, Duke-NUS Khoo Pilot Award (Collaborative) 2021, National Cancer Centre, Singapore, National Neuroscience Institute Singapore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance characteristics of FET PET in differentiating pseudoprogression from tumour progression in patients with equivocal conventional imaging	Sensitivity and specificity of [18F]FET-PET in delineating disease.	1 year