About this trial
MRI is used in clinical routine for diagnosing brain tumors, but has limitations in identifying tumor grade, true tumor extension and differentiate viable tumor tissue from treatment induced changes and recurrences.
Amino acid PET has demonstrated a great potential for defining true tumor volume, differentiate viable tumor tissue from postoperative changes or radiation necrosis, selection of biopsy site, non-invasive grading of gliomas and for treatment planning and therapy response assessment. By combining PET with MRI, the diagnostic accuracy can improve significantly for these patients. More research is however needed to compare the most promising amino acid PET tracers in patients with glioma, but also to assess the diagnostic value of amino acid PET in patients with different brain metastases, where the knowledge concerning the uptake characteristics is limited.
Three of the most promising amino acid tracers (\[11C\]-methyl-methionine (11C-MET), \[18F\] fluoro-ethyl-tyrosin (18F-FET) and anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (18F-FACBC)) will be evaluated in 3 substudies in this project; WP1 Aminoacid PET/MRI in low and high grade glioma; WP2 Role of 11C-MET in high-grade glioma Gamma Knife® radiosurgery; and WP3 Amino acid PET in brain metastasis.
The main aim of the study is to improve diagnostic accuracy, histopathological tissue sampling, delineation of tumor extent and therapy response assessment in gliomas and brain metastases with amino acid PET/MRI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Planned treatment for WHO grade II-IV diffuse glioma
Adult patients (>18 years)
Planned tissue sampling for histopathological diagnosis.
KPS >60 (able to care for self)
Disqualifiers
Pacemakers or defibrillators not compatible with 3T MRI
No ability to obtain informed consent (e.g. due to severe dysphasia or cognitive deficits).
Pregnancy (pregnancy test for all women in fertile age when doubt about possible pregnancy exist)
Breastfeeding
Trial population
* 20 low-grade glioma (LGG) patients * 40 high-grade glioma (HGG) * 30 recurrent HGG patients * 70 Patients with brain metastases
Trial design
Case-only
Prospective
Treatments tested in this trial
Diagnostic Amino acid PET/MRI examination
Other interventionDiagnostic Amino acid PET/MRI examination
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic accuracy in detecting brain tumor tissue at baseline
Diagnostic accuracy, sensitivity, specificity, positive-and negative predictive values of PET, contrast-enhanced MRI (MRICE) and combined PET/MRI will be calculated by comparing images to histopathological results for the large non-localized biopsies as well as to the image-localized biopsies taken prior to resection.
Secondary outcomes
Diagnostic accuracy using dynamic PET
Dynamic PET will be compared for differentiation between low-grade and high-grade tumors and to study the relationship between the time-activity-curve pattern and histology type.
Differentiation between recurrence and treatment related changes using PET/MRI
18F-FACBC uptake (at follow-up), in terms of SUV, TBR, and TAC will be compared to MRI and baseline-PET to evaluate if PET can detect recurrent disease prior to MRI, or if PET can define early treatment response better than MRI.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Norwegian University of Science and Technology
Lead sponsor
St. Olavs Hospital
Collaborator
University of Bergen
Collaborator
Haukeland University Hospital
Collaborator
University of Tromso
Collaborator
University Hospital of North Norway
Collaborator