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RecruitingNCT06263361Updated Jun 11, 2025

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

An observational study in Cerebral Lymphoma, sponsored by IRCCS San Raffaele. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-11.

Sponsored by IRCCS San Raffaele · Observational

From the registry’s dates

  • Started Oct 2021; still recruiting 5 years later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
15
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Cerebral Lymphoma

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03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 15 is below the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

IRCCS San Raffaele is the lead sponsor of 443 studies on the registry; 234 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients, undergoing stereotactic biopsy for newly diagnosed PSNCLs at our Institution, able to express informed consent.

Inclusion criteria

  • Adult patients, undergoing stereotactic biopsy for newly diagnosed PSNCLs

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
15 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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).

    Diagnostic Test: MRI imaging · Diagnostic Test: Cerebral biopsy

Interventions

  • Diagnostic testMRI imaging

    To characterize the peritumoral area in PCNLs through the use of advanced MRI sequences.

  • Diagnostic testCerebral biopsy

    To evaluate the predictive value of sodium fluorescence to confirm ex-vivo the diagnostic tumor tissue prior to histopathological examination.

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What researchers measure

Primary outcomes

  1. MRI imaging

    Peritumoral area (PTA) volumes in T1w sequence Units: cm3.

    Time frame: Baseline (before surgery)

  2. MRI imaging

    Peritumoral area (PTA) volumes in T2w sequence. Units: cm3.

    Time frame: Baseline (before surgery)

  3. MRI imaging

    Peritumoral area (PTA) volumes in FLAIR sequence. Units: cm3.

    Time frame: Baseline (before surgery)

  4. MRI imaging

    Peritumoral area (PTA) mean ADC value in PTA. Units: mm2/s

    Time frame: Baseline (before surgery)

  5. Define immunopathological features

    Number of immune cells infiltrating the lesion. Units: number/mm3

    Time frame: 1 week after surgical procedure

Secondary outcomes

  1. Accuracy of fluoresceine guided stereotactic biopsy

    Number of patients with samples positively stained with fluoresceine. Units: number of samples/patients

    Time frame: 1 week after surgical procedure

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Study locations

1 of 1 sites recruiting
  • IRCCS San Raffaele Scientific Institute
    Milan, 20132, Italy
    Recruiting
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References and documents

Publications

  • 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. PubMed 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. PubMed 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 Lymphoma Collaborative Group (IPCG). Neuro Oncol. 2021 Jul 1;23(7):1056-1071. doi: 10.1093/neuonc/noab020. PubMed 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. PubMed 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. PubMed 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.CCR-17-1184. Epub 2017 Oct 10. PubMed 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. PubMed 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. PubMed 18224529 ↗
  • 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. PubMed 23851210 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06263361
Lead sponsor
IRCCS San Raffaele
Responsible party
Pietro Mortini, MD, Prof. (Professor, Head of Department, IRCCS San Raffaele) — Principal investigator
First posted
Feb 16, 2024
Start date
Oct 1, 2021
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Jun 11, 2025

Study contacts

Laura Sincinelli
Contact
sincinelli.laura@hsr.it
+390226435568
Pietro Mortini, MD, Prof.
study director · IRCCS San Raffaele Scientific Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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