Clinical trial NCT06263361: Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma.
Official title: Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma (PCNSL): Integration of Advanced MRI Patterns and Fluorescein Sodium Fluorescence
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Lymphoma
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients, undergoing stereotactic biopsy for newly diagnosed PSNCLs at our Institution, able to express informed consent.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Adult patients, undergoing stereotactic biopsy for newly diagnosed PSNCLs

Exclusion Criteria:

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

Primary outcomes:
measure: MRI imaging
timeFrame: Baseline (before surgery)
measure: MRI imaging
timeFrame: Baseline (before surgery)
measure: MRI imaging
timeFrame: Baseline (before surgery)
measure: MRI imaging
timeFrame: Baseline (before surgery)
measure: Define immunopathological features
timeFrame: 1 week after surgical procedure
Secondary outcomes:
measure: Accuracy of fluoresceine guided stereotactic biopsy
timeFrame: 1 week after surgical procedure
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Scientific Institute
Study officials:
affiliation: IRCCS San Raffaele Scientific Institute
name: Pietro Mortini, MD, Prof.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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 Lymphoma Collaborative Group (IPCG). Neuro Oncol. 2021 Jul 1;23(7):1056-1071. doi: 10.1093/neuonc/noab020.
citation: 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.
citation: 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.
citation: 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.CCR-17-1184. Epub 2017 Oct 10.
citation: 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.
citation: 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.
citation: Li Y, Rey-Dios R, Roberts DW, Valdes PA, Cohen-Gadol AA. Intraoperative fluorescence-guided resection of high-grade gliomas: a comparison of the present techniques and evolution of future strategies. World Neurosurg. 2014 Jul-Aug;82(1-2):175-85. doi: 10.1016/j.wneu.2013.06.014. Epub 2013 Jul 9.