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

Обзор

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.

Вмешательства

• Другое Diagnostic Amino acid PET/MRI examination
  Diagnostic Amino acid PET/MRI examination

Первичные конечные точки

• Diagnostic accuracy in detecting brain tumor tissue at baseline [Срок оценки: Baseline]

Вторичные конечные точки (2)

• Diagnostic accuracy using dynamic PET [Срок оценки: Baseline]
• Differentiation between recurrence and treatment related changes using PET/MRI [Срок оценки: 4-6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Норвегия · 3 центра

• Haukeland universitetssykehus — Bergen
• Universitetssykehus Nord Norge — Tromsø
• St Olavs Hospital — Trondheim

Публикации

• 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 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. PMID 34081125

Идентификаторы

NCT: NCT04111588 · 2018/2243

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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