FET PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Glioma
NCT ID: NCT06172595
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
22 participants
INTERVENTIONAL
2023-12-21
2026-02-28
Brief Summary
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* 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
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous bevacizumab or other vascular endothelial growth factor (VEGF) targeting agents or anti-angiogenic treatments.
* Proven cerebral metastases
* IDH-mutated gliomas
* Pregnancy/ breast-feeding
21 Years
ALL
No
Sponsors
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National Cancer Centre, Singapore
OTHER
National Neuroscience Institute Singapore
UNKNOWN
Duke-NUS Graduate Medical School
OTHER
Singapore General Hospital
OTHER
Responsible Party
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Locations
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National Cancer Centre Singapore
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
Countries
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Facility Contacts
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Other Identifiers
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202112-00050
Identifier Type: -
Identifier Source: org_study_id