Diagnostic Assessment of Amino Acid PET/MRI in the Evaluation of Glioma and Brain Metastases
NCT ID: NCT04111588
Last Updated: 2025-06-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
160 participants
OBSERVATIONAL
2019-11-25
2027-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Glioma
20 low-grade (LGG) and 40 high-grade glioma (HGG) patients will be included from the Department of Neurosurgery at St. Olavs Hospital and the Department of Neurosurgery at the University hospital of North Norway and examined with 18F-FACBC PET/MRI at baseline and 4-6 months after surgery. Furthermore, 10 of the LGG patients and 10 of the HGG patients will be examined with an additional 18F-FET PET/MRI at baseline for comparison with 18F-FACBC.
30 recurrent HGG patients will be recruited from the Department of Neurosurgery and the Department of Oncology at the Haukeland University Hospital. These patients will be examined with 11C-MET PET/MRI at treatment/baseline and 1 month after radiosurgery.
Diagnostic Amino acid PET/MRI examination
Diagnostic Amino acid PET/MRI examination
Brain Metastases
Patients with brain metastases (18F-FACBC: n=20, 18F-FET: n=20 and 11C-MET: n=30) will be included from the Department of Neurosurgery at St. Olavs Hospital, the Department of Neurosurgery at Haukeland University Hospital and the Department of Neurosurgery at the University hospital of North Norway, and examined with amino acid PET/MRI at baseline, 1 month after surgery/stereotactic radiosurgery (St. Olavs Hospital/UNN: Linac, Haukeland University Hospital: Gamma Knife® radiosurgery) and at suspicion of recurrence.
Diagnostic Amino acid PET/MRI examination
Diagnostic Amino acid PET/MRI examination
Interventions
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Diagnostic Amino acid PET/MRI examination
Diagnostic Amino acid PET/MRI examination
Eligibility Criteria
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Inclusion Criteria
* Adult patients (\>18 years)
* Planned tissue sampling for histopathological diagnosis.
* KPS \>60 (able to care for self)
* 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
* 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
18 Years
ALL
No
Sponsors
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St. Olavs Hospital
OTHER
University of Bergen
OTHER
Haukeland University Hospital
OTHER
University of Tromso
OTHER
University Hospital of North Norway
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Live Eikenes, Phd
Role: PRINCIPAL_INVESTIGATOR
Norwegian University of Science and Technology
Øystein Risa
Role: STUDY_DIRECTOR
Norwegian University for Science and Technology
Locations
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Haukeland universitetssykehus
Bergen, , Norway
Universitetssykehus Nord Norge
Tromsø, , Norway
St Olavs Hospital
Trondheim, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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Karlberg A, Pedersen LK, Vindstad BE, Skjulsvik AJ, Johansen H, Solheim O, Skogen K, Kvistad KA, Bogsrud TV, Myrmel KS, Giskeodegard GF, Ingebrigtsen T, Berntsen EM, Eikenes L. Diagnostic accuracy of anti-3-[18F]-FACBC PET/MRI in gliomas. Eur J Nucl Med Mol Imaging. 2024 Jan;51(2):496-509. doi: 10.1007/s00259-023-06437-4. Epub 2023 Sep 30.
Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.
Other Identifiers
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2018/2243
Identifier Type: -
Identifier Source: org_study_id
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