Diagnostic Assessment of Amino Acid PET/MRI in the Evaluation of Glioma and Brain Metastases
Data Collection
Collected from today forward - ProspectiveBrain Diseases+8
+ Brain Neoplasms
+ Central Nervous System Diseases
Case-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: November 25, 2019
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.160 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Inclusion criteria Glioma (LGG, HGG and recurrent HGG): * 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) Inclusion criteria Brain Metastasis: * Indication of surgery or stereotactic radiosurgery for 1-4 brain metastases * Planned surgery: Suspicion of brain metastasis or known diagnosis * Stereotactic surgery: Known primary cancer * Adult patients (\>18 years) * Estimated survival at least 3 months after inclusion Exclusion Criteria: * Exclusion criteria (Glioma and Brain Metastasis): * 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 * Weight \> 120 kg
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Haukeland universitetssykehus
Bergen, NorwayUniversitetssykehus Nord Norge
Tromsø, Norway