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

Study Purpose

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 Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	21 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06172595
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Singapore General Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Glioma, Malignant

Arms & Interventions

Arms

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.

Interventions

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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