Using FET PET to Distinguish Tumor Progression from Pseudoprogression in High-Grade Glioma
18F-FET (O-(2-[18F]Fluoroethyl)-L-tyrosine) PET in Differentiating Tumour Progression From Pseudoprogression in High Grade Gliomas
PHASE2 · Singapore General Hospital · NCT06172595
This study is testing if a special brain scan can help tell the difference between real tumor growth and false alarms in patients with high-grade gliomas after radiation therapy.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 21 Years and up |
| Sex | All |
| Sponsor | Singapore General Hospital (other) |
| Drugs / interventions | bevacizumab |
| Locations | 2 sites (Singapore and 1 other locations) |
| Trial ID | NCT06172595 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of O-(2-[18F]fluoroethyl)-L-tyrosine (FET) PET imaging in differentiating between true tumor progression and pseudoprogression in patients with high-grade gliomas. Participants will undergo a limited FET PET/CT scan of the brain to assess the diagnostic accuracy of this imaging technique. The study aims to optimize threshold cut-offs for various parameters to improve the sensitivity and specificity of FET PET in identifying disease progression. The trial focuses on patients with equivocal conventional imaging results following radiation therapy.
Who should consider this trial
Good fit: Ideal candidates include adults aged 21 and older with histologically confirmed malignant glioma who have undergone prior radiation therapy and exhibit enlarging lesions on MRI.
Not a fit: Patients with low-grade gliomas, IDH-mutated gliomas, or those who have received anti-angiogenic treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate diagnostic tool for distinguishing between tumor progression and pseudoprogression, leading to better treatment decisions for patients with high-grade gliomas.
How similar studies have performed: Other studies have shown promising results using advanced PET imaging techniques for similar diagnostic challenges, indicating potential success for this approach.
Eligibility criteria
Show full 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
Where this trial is running
Singapore and 1 other locations
- National Cancer Centre Singapore — Singapore, Singapore (RECRUITING)
- Singapore General Hospital — Singapore, Singapore (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glioma, Malignant