Clinical trial NCT04111588: Diagnostic Assessment of Amino Acid PET/MRI in the Evaluation of Glioma and Brain Metastases
Official title: Diagnostic Assessment of Amino Acid PET/MRI in the Evaluation of Glioma and Brain Metastases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Brain Neoplasms
Keywords: Diagnosis
Magnetic Resonance Imaging
Positron-Emission Tomography
PET-tracer
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: University of Bergen
name: Haukeland University Hospital
name: University of Tromso
name: University Hospital of North Norway
First posted: 2019-10-01
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * 20 low-grade glioma (LGG) patients
* 40 high-grade glioma (HGG)
* 30 recurrent HGG patients
* 70 Patients with brain metastases

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

Primary outcomes:
measure: Diagnostic accuracy in detecting brain tumor tissue at baseline
timeFrame: Baseline
Secondary outcomes:
measure: Diagnostic accuracy using dynamic PET
timeFrame: Baseline
measure: Differentiation between recurrence and treatment related changes using PET/MRI
timeFrame: 4-6 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland universitetssykehus
city: Tromsø
country: Norway
facility: Universitetssykehus Nord Norge
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Live Eikenes, Phd
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University for Science and Technology
name: Øystein Risa
role: STUDY_DIRECTOR
References:
citation: 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.