Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma.

Официальное название

Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma (PCNSL): Integration of Advanced MRI Patterns and Fluorescein Sodium Fluorescence

Обзор

Primary central nervous system lymphoma (PCNSL) is an aggressive extranodal non- Hodgkin lymphoma exclusively localized into the nervous system. The aim of this study is to evaluate the MRI imaging characteristics of the peritumoral area (PTA) and to correlate this information to pathological findings.

Подробное описание

Primary central nervous system lymphoma (PCNSL) is an aggressive extranodal non- Hodgkin lymphoma exclusively localized into the nervous system. It is a relatively rare disorder, accounting for only 3% of all primary brain tumors but due to its anatomical localization represents an important clinical and diagnostic challenge in onco-hematology. different MRI patterns of the peritumoral area (PTA) might correlate with different histopathological sensitivity regarding diagnostic potential out of contrast-enhanced region (CER). Improvements in the understanding of PTA diagnostic potentials is of great help in diagnosing patients with deep-seated lesions, who would otherwise be not eligible for stereotactic biopsy and therefore for a consequent adequate treatment.

Вмешательства

• Диагностический тест MRI imaging
  To characterize the peritumoral area in PCNLs through the use of advanced MRI sequences.
• Диагностический тест Cerebral biopsy
  To evaluate the predictive value of sodium fluorescence to confirm ex-vivo the diagnostic tumor tissue prior to histopathological examination.

Первичные конечные точки

• MRI imaging [Срок оценки: Baseline (before surgery)]
• MRI imaging [Срок оценки: Baseline (before surgery)]
• MRI imaging [Срок оценки: Baseline (before surgery)]
• MRI imaging [Срок оценки: Baseline (before surgery)]
• Define immunopathological features [Срок оценки: 1 week after surgical procedure]

Вторичные конечные точки (1)

• Accuracy of fluoresceine guided stereotactic biopsy [Срок оценки: 1 week after surgical procedure]

Критерии участия

Критерии включения

• Adult patients, undergoing stereotactic biopsy for newly diagnosed PSNCLs

Критерии исключения

• Severe hepatic dysfunction
• Severe renal dysfunction
• Severe heart failure
• myocardial infarction and stroke within 90 days
• Hyperreactivity against contrast agents
• Pregnancy

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

Италия · 1 центр

• IRCCS San Raffaele Scientific Institute — Milan

Публикации

• Akshulakov SK, Kerimbayev TT, Biryuchkov MY, Urunbayev YA, Farhadi DS, Byvaltsev VA. Current Trends for Improving Safety of Stereotactic Brain Biopsies: Advanced Optical Methods for Vessel Avoidance and Tumor Detection. Front Oncol. 2019 Oct 2;9:947. doi: 10.3389/fonc.2019.00947. eCollection 2019. PMID 31632903
• Barajas RF Jr, Rubenstein JL, Chang JS, Hwang J, Cha S. Diffusion-weighted MR imaging derived apparent diffusion coefficient is predictive of clinical outcome in primary central nervous system lymphoma. AJNR Am J Neuroradiol. 2010 Jan;31(1):60-6. doi: 10.3174/ajnr.A1750. Epub 2009 Sep 3. PMID 19729544
• Barajas RF, Politi LS, Anzalone N, Schoder H, Fox CP, Boxerman JL, Kaufmann TJ, Quarles CC, Ellingson BM, Auer D, Andronesi OC, Ferreri AJM, Mrugala MM, Grommes C, Neuwelt EA, Ambady P, Rubenstein JL, Illerhaus G, Nagane M, Batchelor TT, Hu LS. Consensus recommendations for MRI and PET imaging of primary central nervous system lymphoma: guideline statement from the International Primary CNS Lympho PMID 33560416
• Harris N, Fetter RD, Brasier DJ, Tong A, Davis GW. Molecular Interface of Neuronal Innate Immunity, Synaptic Vesicle Stabilization, and Presynaptic Homeostatic Plasticity. Neuron. 2018 Dec 5;100(5):1163-1179.e4. doi: 10.1016/j.neuron.2018.09.048. Epub 2018 Oct 18. PMID 30344041
• Chen B, Wang H, Ge P, Zhao J, Li W, Gu H, Wang G, Luo Y, Chen D. Gross total resection of glioma with the intraoperative fluorescence-guidance of fluorescein sodium. Int J Med Sci. 2012;9(8):708-14. doi: 10.7150/ijms.4843. Epub 2012 Oct 6. PMID 23091408
• Acerbi F, Broggi M, Schebesch KM, Hohne J, Cavallo C, De Laurentis C, Eoli M, Anghileri E, Servida M, Boffano C, Pollo B, Schiariti M, Visintini S, Montomoli C, Bosio L, La Corte E, Broggi G, Brawanski A, Ferroli P. Fluorescein-Guided Surgery for Resection of High-Grade Gliomas: A Multicentric Prospective Phase II Study (FLUOGLIO). Clin Cancer Res. 2018 Jan 1;24(1):52-61. doi: 10.1158/1078-0432.CC PMID 29018053
• Hamamcioglu MK, Akcakaya MO, Goker B, Kasimcan MO, Kiris T. The use of the YELLOW 560 nm surgical microscope filter for sodium fluorescein-guided resection of brain tumors: Our preliminary results in a series of 28 patients. Clin Neurol Neurosurg. 2016 Apr;143:39-45. doi: 10.1016/j.clineuro.2016.02.006. Epub 2016 Feb 11. PMID 26895208
• Koc K, Anik I, Cabuk B, Ceylan S. Fluorescein sodium-guided surgery in glioblastoma multiforme: a prospective evaluation. Br J Neurosurg. 2008 Feb;22(1):99-103. doi: 10.1080/02688690701765524. PMID 18224529

Идентификаторы

NCT: NCT06263361 · NCH02-2021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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