Diagnostic Assessment of Amino Acid PET/MRI in the Evaluation of Glioma and Brain Metastases
1 other identifier
observational
160
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2019
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2019
CompletedFirst Posted
Study publicly available on registry
October 1, 2019
CompletedStudy Start
First participant enrolled
November 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedJune 22, 2025
May 1, 2025
6.1 years
September 28, 2019
June 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diagnostic accuracy in detecting brain tumor tissue at 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.
Baseline
Secondary Outcomes (2)
Diagnostic accuracy using dynamic PET
Baseline
Differentiation between recurrence and treatment related changes using PET/MRI
4-6 months
Study Arms (2)
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.
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.
Interventions
Diagnostic Amino acid PET/MRI examination
Eligibility Criteria
* 20 low-grade glioma (LGG) patients * 40 high-grade glioma (HGG) * 30 recurrent HGG patients * 70 Patients with brain metastases
You may qualify if:
- 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)
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
- University of Bergencollaborator
- Haukeland University Hospitalcollaborator
- University of Tromsocollaborator
- University Hospital of North Norwaycollaborator
Study Sites (3)
Haukeland universitetssykehus
Bergen, Norway
Universitetssykehus Nord Norge
Tromsø, Norway
St Olavs Hospital
Trondheim, Norway
Related Publications (2)
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.
PMID: 37776502DERIVEDKotecha 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.
PMID: 34081125DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Live Eikenes, Phd
Norwegian University of Science and Technology
- STUDY DIRECTOR
Øystein Risa
Norwegian University for Science and Technology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2019
First Posted
October 1, 2019
Study Start
November 25, 2019
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2027
Last Updated
June 22, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share