Diagnostic accuracy of anti-3-[18F]-FACBC PET/MRI in gliomas.
Anna Karlberg, Lars Kjelsberg Pedersen, Benedikte Emilie Vindstad...
https://pubmed.ncbi.nlm.nih.gov/37776502Actively Recruiting
Age: 18Years +
All Genders
ID04111588
Diagnostic Assessment of Amino Acid PET/MRI in Glioma and Brain Metastases Evaluation
Led by Norwegian University of Science and Technology · Updated on 2025-06-22
160
Participants Needed
3
Research Sites
104 weeks
Total Duration
On this page
Sponsors
N
Norwegian University of Science and Technology
Lead Sponsor
S
St. Olavs Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the use of amino acid PET combined with MRI to improve the diagnosis and assessment of brain tumors, specifically gliomas and brain metastases. The study aims to overcome limitations of MRI alone in identifying tumor grade, extent, and distinguishing viable tumor tissue from treatment effects or recurrences. Three promising amino acid PET tracers (11C-MET, 18F-FET, and 18F-FACBC) are being evaluated to enhance diagnostic accuracy and treatment planning for these brain conditions. The study includes three substudies: one involving 20 low-grade and 40 high-grade glioma patients examined with 18F-FACBC PET/MRI at baseline and 4-6 months post-surgery, with some also receiving 18F-FET PET/MRI for comparison; another focusing on 30 recurrent high-grade glioma patients undergoing 11C-MET PET/MRI at baseline and one month after Gamma Knife radiosurgery; and a third enrolling patients with brain metastases who will receive amino acid PET/MRI at baseline, one month after surgery or stereotactic radiosurgery, and when recurrence is suspected. Participants will undergo PET/MRI scans at specified time points depending on their diagnosis and treatment plan. Researchers will assess diagnostic accuracy in detecting tumor tissue, differentiate recurrence from treatment-induced changes, and evaluate therapy response. The study monitors patients’ health status and imaging results over several months to improve brain tumor diagnosis and management. Total participation time varies by subgroup and treatment schedule.
CONDITIONS
Brief Title
Diagnostic Assessment of Amino Acid PET/MRI in the Evaluation of Glioma and Brain Metastases
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Planned treatment for WHO grade II-IV diffuse glioma
- Adult patients older than 18 years
- Planned tissue sampling for histopathological diagnosis
- Karnofsky Performance Status (KPS) above 60 (able to care for self)
- Indication for surgery or stereotactic radiosurgery for 1-4 brain metastases
- Planned surgery with suspicion or known diagnosis of brain metastasis
- Known primary cancer for stereotactic radiosurgery
- Estimated survival of at least 3 months after inclusion
You will not qualify if you...
- Pacemakers or defibrillators not compatible with 3T MRI
- Inability to provide informed consent (e.g., severe dysphasia or cognitive deficits)
- Pregnancy (confirmed by pregnancy test if applicable)
- Breastfeeding
- Weight over 120 kg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - Baseline and up to 6 months after surgery or radiosurgery
Participants undergo amino acid PET/MRI examinations to evaluate brain tumors at baseline and additional scans depending on their condition.
1 to 3 visits depending on treatment and follow-up schedule
Long-term Monitoring
Duration - Up to several months after treatment
Participants are monitored for recurrence or treatment-related changes through follow-up PET/MRI scans after initial treatment.
Visits at 1 month post-surgery/radiosurgery and at suspicion of recurrence
Trial Site Locations
Total: 3 locations
1
Haukeland universitetssykehus
Bergen, Norway
Not Yet Recruiting
2
Universitetssykehus Nord Norge
Tromsø, Norway
Not Yet Recruiting
3
St Olavs Hospital
Trondheim, Norway
Actively Recruiting
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Research Team
L
Live Eikenes, PhD
A
Anna Karlberg, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation.
Rupesh Kotecha, Mariam Aboian, Seyed Ali Nabavizadeh...
https://pubmed.ncbi.nlm.nih.gov/34081125