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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04111588
Enrollment
160
Registered
2019-10-01
Start date
2019-11-25
Completion date
2027-12-31
Last updated
2025-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Neoplasms

Keywords

Diagnosis, Magnetic Resonance Imaging, Positron-Emission Tomography, PET-tracer

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.

Interventions

OTHERDiagnostic Amino acid PET/MRI examination

Diagnostic Amino acid PET/MRI examination

Sponsors

St. Olavs Hospital
CollaboratorOTHER
University of Bergen
CollaboratorOTHER
Haukeland University Hospital
CollaboratorOTHER
University of Tromso
CollaboratorOTHER
University Hospital of North Norway
CollaboratorOTHER
Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

*

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy in detecting brain tumor tissue at baselineBaselineDiagnostic 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

MeasureTime frameDescription
Diagnostic accuracy using dynamic PETBaselineDynamic 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.
Differentiation between recurrence and treatment related changes using PET/MRI4-6 months18F-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.

Countries

Norway

Contacts

Primary ContactLive Eikenes, PhD
live.eikenes@ntnu.no0047 99568081
Backup ContactAnna Karlberg, PhD
anna.karlberg@ntnu.no0047 40489126

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026