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NCT Number: NCT04111588

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

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.

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Key information

Conditions

Brain Neoplasms Brain Diseases Central Nervous System Diseases Central Nervous System Neoplasms Disease Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland universitetssykehus, Bergen, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diagnostic Amino acid PET/MRI examination

Other

Diagnostic Amino acid PET/MRI examination

Primary outcomes

  1. Diagnostic accuracy in detecting brain tumor tissue at baseline

    Time frame: 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

  1. Diagnostic accuracy using dynamic PET

    Time frame: Baseline

    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.

  2. Differentiation between recurrence and treatment related changes using PET/MRI

    Time frame: 4-6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Karlberg, PhD

CONTACT

[email protected]

0047 40489126

Live Eikenes, PhD

CONTACT

[email protected]

0047 99568081

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Haukeland University Hospital
  • St. Olavs Hospital
  • University Hospital of North Norway
  • University of Bergen
  • University of Tromso

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
Oct 1, 2019
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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