Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma.
NCT ID: NCT06263361
Last Updated: 2025-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
15 participants
OBSERVATIONAL
2021-10-01
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Included patients
Adult patients (\>18 years) candidates to stereotactic biopsy for histopathological diagnosis of intra-axial lesions suspected for primary central nervous system lymphoma (PCNSLs).
MRI imaging
To characterize the peritumoral area in PCNLs through the use of advanced MRI sequences.
Cerebral biopsy
To evaluate the predictive value of sodium fluorescence to confirm ex-vivo the diagnostic tumor tissue prior to histopathological examination.
Interventions
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MRI imaging
To characterize the peritumoral area in PCNLs through the use of advanced MRI sequences.
Cerebral biopsy
To evaluate the predictive value of sodium fluorescence to confirm ex-vivo the diagnostic tumor tissue prior to histopathological examination.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Severe renal dysfunction
* Severe heart failure
* myocardial infarction and stroke within 90 days
* Hyperreactivity against contrast agents
* Pregnancy
18 Years
ALL
No
Sponsors
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IRCCS San Raffaele
OTHER
Responsible Party
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Pietro Mortini, MD, Prof.
Professor, Head of Department
Principal Investigators
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Pietro Mortini, MD, Prof.
Role: STUDY_DIRECTOR
IRCCS San Raffaele Scientific Institute
Locations
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IRCCS San Raffaele Scientific Institute
Milan, Milan, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NCH02-2021
Identifier Type: -
Identifier Source: org_study_id
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