[18F]-fluoro-ethyl-L-tyrosine PET: a valuable diagnostic tool in neuro-oncology, but not all that glitters is glioma.
Markus Hutterer, Martha Nowosielski, Daniel Putzer...
https://pubmed.ncbi.nlm.nih.gov/23335162Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06466031
Application of FET-PET in Fusion With MRI in the Surgical Treatment and Postoperative Radiotherapy of Glioblastoma Multiforme - a Randomized, Blinded, Prospective Study
Led by Copernicus Memorial Hospital · Updated on 2026-04-17
189
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
Copernicus Memorial Hospital
Lead Sponsor
M
Medical Research Agency, Poland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Glioblastoma multiforme (GBM WHO IV) is an aggressive primary brain tumor affecting mostly adults in their productive years, with a poor prognosis and median survival of 12-16 months. The standard treatment includes maximal safe surgical removal followed by radiotherapy and chemotherapy according to the Stupp protocol. However, conventional MRI lacks the sensitivity to define true tumor boundaries, leading to frequent local tumor recurrence driven by infiltrating glioblastoma stem cells. This trial investigates using fused 18F-fluoroethyl-L-tyrosine (18F-FET) PET and contrast-enhanced MRI to better guide surgery and radiotherapy in glioblastoma treatment. Participants will be randomly assigned to one of three groups: surgery and radiotherapy planned using fused FET-PET and MRI; surgery planned using MRI only with radiotherapy planned using fused FET-PET and MRI; or surgery and radiotherapy planned using MRI alone. The fused imaging aims to more precisely define tumor margins for removal and targeting, potentially reducing residual tumor cells. Surgery will be carefully stopped based on PET tumor margin or neurological monitoring. Radiotherapy planning also incorporates these imaging findings. Throughout the study, participants will undergo evaluations including MRI and PET imaging before radiotherapy, quality of life assessments at several time points, and monitoring of tumor volume and recurrence patterns. The main outcomes measured are progression-free and overall survival up to 36 months post-surgery. Additional assessments include tumor volume comparison between imaging methods, long-term survival, recurrence location, and quality of life related to tumor progression. This comprehensive monitoring aims to evaluate whether fused imaging improves treatment precision and patient outcomes.
CONDITIONS
Brief Title
Application of FET-PET in Fusion With MRI in the Treatment of Glioblastoma Multiforme [TYR-GLIO]
Who Can Participate
Age: 18Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Single macroscopic tumor on MRI with contrast appearing as glioblastoma multiforme with contrast-enhancing lesion, possibly with central necrosis and surrounding edema
- No history of cancer in other organs and no suspicious lesions on chest and abdomen imaging
- No clinical signs or suspicion of brain abscess or neuroinfection
- Primary tumor with no prior neurosurgical, radiotherapy, or oncology treatment; prior biopsy allowed
- Tumor suitable for surgical treatment by craniotomy and resection
- Age 18 years or older but less than 70 years
- Karnofsky Performance Status (KPS) score of 70 or higher
- Informed consent given for participation and treatment
- No allergy to contrast agents used in PET and MRI
- No medical contraindications for neurosurgery including craniotomy and tumor resection
You will not qualify if you...
- Multifocal brain tumors
- Recurrence of glioblastoma multiforme
- Clinical or radiological suspicion of brain metastasis or brain abscess
- Postoperative pathology other than WHO grade IV glioblastoma
- Medical contraindications to surgery under general anesthesia
- Pregnancy or breastfeeding
- Known allergy to gadolinium contrast agents or radiopharmaceutical tracers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - 1 day
Participants undergo tumor resection planned based on MRI and PET imaging fusion or MRI alone, depending on their assigned group.
1 surgical procedure
Post-operative Follow-up
Duration - Up to 7 days post surgery
Participants have assessments including MRI and PET imaging to evaluate tumor volume and planned radiotherapy volume, as well as quality of life assessments.
3 visits (including 7 days post surgery and 1 day before and after radiotherapy)
Radiotherapy Treatment
Duration - Duration as per radiotherapy schedule (not specified)
Participants receive radiotherapy planned according to their imaging group assignment, based on MRI and PET fusion or MRI alone.
Visit schedule not specified
Long-term Monitoring
Duration - Up to 36 months post surgery
Participants are monitored for progression-free survival, overall survival, tumor recurrence patterns, and long-term quality of life for up to 36 months post surgery.
Visit schedule not specified
Trial Site Locations
Total: 1 location
1
Copernicus Memorial Hospital in Łódź, Poland
Lodz, Łódź Voivodeship, Poland, 93-513
Actively Recruiting
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Research Team
K
Kamil Krystkiewicz, PhD
M
Marcin Tosik, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
Performance of 18F-FET versus 18F-FDG-PET for the diagnosis and grading of brain tumors: systematic review and meta-analysis.
Vincent Dunet, Anastasia Pomoni, Andreas Hottinger...
https://pubmed.ncbi.nlm.nih.gov/26243791Contribution of [18F]FET PET in the Management of Gliomas, from Diagnosis to Follow-Up: A Review.
Jade Apolline Robert, Arthur Leclerc, Mathilde Ducloie...
https://pubmed.ncbi.nlm.nih.gov/3933839018F-FET-PET-guided gross total resection improves overall survival in patients with WHO grade III/IV glioma: moving towards a multimodal imaging-guided resection.
Jonas Ort, Hussam Aldin Hamou, Julius M Kernbach...
https://pubmed.ncbi.nlm.nih.gov/34599479Combining amino acid PET and MRI imaging increases accuracy to define malignant areas in adult glioma.
Maciej Harat, Józefina Rakowska, Marek Harat...
https://pubmed.ncbi.nlm.nih.gov/3751676211C-methionine PET for differential diagnosis of low-grade gliomas.
K Herholz, T Hölzer, B Bauer...
https://pubmed.ncbi.nlm.nih.gov/9595980Delineation of brain tumor extent with [11C]L-methionine positron emission tomography: local comparison with stereotactic histopathology.
Lutz W Kracht, Hrvoje Miletic, Susanne Busch...
https://pubmed.ncbi.nlm.nih.gov/1553408811C-L-methionine positron emission tomography in the clinical management of cerebral gliomas.
Tarun Singhal, Tanjore K Narayanan, Viney Jain...
https://pubmed.ncbi.nlm.nih.gov/17957408L-(methyl-11C) methionine positron emission tomography for target delineation in resected high-grade gliomas before radiotherapy.
Anca-Ligia Grosu, Wolfgang A Weber, Eva Riedel...
https://pubmed.ncbi.nlm.nih.gov/16111573Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients - a report of the PET/RANO group.
Norbert Galldiks, Maximilian Niyazi, Anca L Grosu...
https://pubmed.ncbi.nlm.nih.gov/33538838