Actively Recruiting

Age: 18Years +
All Genders
NCT04111588

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

Led by Norwegian University of Science and Technology · Updated on 2025-06-22

160

Participants Needed

3

Research Sites

422 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

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.

CONDITIONS

Official 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

Eligible

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 greater than 60 (able to care for self)
  • Indication for surgery or stereotactic radiosurgery for 1-4 brain metastases
  • For planned surgery: suspicion of brain metastasis or known diagnosis
  • For stereotactic surgery: known primary cancer
  • Estimated survival of at least 3 months after inclusion
Not Eligible

You will not qualify if you...

  • Pacemakers or defibrillators not compatible with 3T MRI
  • Unable to give informed consent due to severe speech or cognitive problems
  • Pregnancy or breastfeeding
  • Weight over 120 kg

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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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

CONTACT

A

Anna Karlberg, PhD

CONTACT

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