NCT04111588 Diagnostic Assessment of Amino Acid PET/MRI in the Evaluation of Glioma and Brain Metastases
| NCT ID | NCT04111588 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Norwegian University of Science and Technology |
| Condition | Brain Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 160 participants |
| Start Date | 2019-11-25 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 160 participants in total. It began in 2019-11-25 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Live Eikenes, Phd
PRINCIPAL INVESTIGATOR
Norwegian University of Science and Technology
Frequently Asked Questions
Who can join the NCT04111588 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04111588 currently recruiting?
Yes, NCT04111588 is actively recruiting participants. Contact the research team at live.eikenes@ntnu.no for enrollment information.
Where is the NCT04111588 trial being conducted?
This trial is being conducted at Bergen, Norway, Tromsø, Norway, Trondheim, Norway.
Who is sponsoring the NCT04111588 clinical trial?
NCT04111588 is sponsored by Norwegian University of Science and Technology. The principal investigator is Live Eikenes, Phd at Norwegian University of Science and Technology. The trial plans to enroll 160 participants.