RecruitingNCT04111588

Diagnostic Assessment of Amino Acid PET/MRI in the Evaluation of Glioma and Brain Metastases


Sponsor

Norwegian University of Science and Technology

Enrollment

160 participants

Start Date

Nov 25, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a special type of brain scan — combining PET (which uses a tracer to highlight active areas) with MRI — to get a better picture of brain tumours and cancer that has spread to the brain. It aims to improve how doctors diagnose and plan treatment for these conditions. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with, or are suspected to have, a brain glioma (WHO grade II, III, or IV) and are scheduled for tissue sampling - OR you have 1 to 4 brain metastases and are scheduled for surgery or focused radiation (stereotactic radiosurgery) - You are able to care for yourself independently (KPS above 60) - Your expected survival is at least 3 months (for brain metastasis group) **You may NOT be eligible if...** - You have a pacemaker or defibrillator incompatible with a 3T MRI - You are unable to give informed consent - You are pregnant or breastfeeding - You weigh more than 120 kg Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERDiagnostic Amino acid PET/MRI examination

Diagnostic Amino acid PET/MRI examination


Locations(3)

Haukeland universitetssykehus

Bergen, Norway

Universitetssykehus Nord Norge

Tromsø, Norway

St Olavs Hospital

Trondheim, Norway

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NCT04111588


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