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

Last updated: June 17, 2025
Sponsor: Norwegian University of Science and Technology
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Diagnostic Amino acid PET/MRI examination

Clinical Study ID

NCT04111588
2018/2243
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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

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 orcognitive deficits).

  • Pregnancy (pregnancy test for all women in fertile age when doubt aboutpossible pregnancy exist)

  • Breastfeeding

  • Weight > 120 kg

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Diagnostic Amino acid PET/MRI examination
Phase:
Study Start date:
November 25, 2019
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Haukeland universitetssykehus

    Bergen,
    Norway

    Site Not Available

  • Universitetssykehus Nord Norge

    Tromsø,
    Norway

    Site Not Available

  • St Olavs Hospital

    Trondheim,
    Norway

    Active - Recruiting

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