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Brain NeoplasmsNCT04111588

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

An observational study of Brain Neoplasms, run by Norwegian University of Science and Technology at 3 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Brain Neoplasms
What is being tested?
Diagnostic Amino acid PET/MRI examination
How many people
160 participants
Where
3 sitesNorway
Study dates
25 Nov 2019to 31 Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: * 20 low-grade glioma (LGG) patients * 40 high-grade glioma (HGG) * 30 recurrent HGG patients * 70 Patients with brain metastases

Who may be able to join

  • 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
Show all 9Show fewer
  • Stereotactic surgery: Known primary cancer
  • Adult patients (>18 years)
  • Estimated survival at least 3 months after inclusion

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Live Eikenes, PhD contact

0047 99568081

live.eikenes@ntnu.no

Anna Karlberg, PhD contact

0047 40489126

anna.karlberg@ntnu.no

Norway3 sites, 3 recruiting

  • Haukeland universitetssykehus

    Bergen

    Not yet recruiting

  • Universitetssykehus Nord Norge

    Tromsø

    Not yet recruiting

  • St Olavs Hospital

    Trondheim

    Live Eikenes, live.eikenes@ntnu.no

    Recruiting

Other trials in Norway

About this study

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.

Read more

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.

Conditions
Brain Neoplasms
Being tested
Diagnostic Amino acid PET/MRI examination
Keywords
Diagnosis, Magnetic Resonance Imaging, Positron-Emission Tomography, PET-tracer
Medical subject headings
Brain Neoplasms, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diagnostic Amino acid PET/MRI examinationOther

    Diagnostic Amino acid PET/MRI examination

Study groups in NCT04111588
Study groupRoleWhat they receive
Glioma20 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.
Receives: Other: Diagnostic Amino acid PET/MRI examination
Brain MetastasesPatients 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.
Receives: Other: Diagnostic Amino acid PET/MRI examination

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

Secondary outcomes (2)

  1. Diagnostic accuracy using dynamic PET

    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.

    Measured: Baseline

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

    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.

    Measured: 4-6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2019
  2. Study start25 Nov 2019
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04111588
Sponsor's protocol ID
2018/2243
Status last verified
May 2025
First submitted
28 Sep 2019
Last updated
22 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37776502

  • 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.

    PubMed 34081125

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Neoplasms, run by Norwegian University of Science and Technology at 3 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Live Eikenes, PhD (0047 99568081, live.eikenes@ntnu.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnostic accuracy in detecting brain tumor tissue at baseline (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04111588, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2025.

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