NCT06263361

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
44mo left

Started Oct 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Oct 2021Dec 2029

Study Start

First participant enrolled

October 1, 2021

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

June 11, 2025

Status Verified

June 1, 2025

Enrollment Period

7.3 years

First QC Date

January 30, 2024

Last Update Submit

June 6, 2025

Conditions

Cerebral Lymphoma

Outcome Measures

Primary Outcomes (5)

  • MRI imaging

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

    Baseline (before surgery)

  • MRI imaging

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

    Baseline (before surgery)

  • MRI imaging

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

    Baseline (before surgery)

  • MRI imaging

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

    Baseline (before surgery)

  • Define immunopathological features

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

    1 week after surgical procedure

Secondary Outcomes (1)

  • Accuracy of fluoresceine guided stereotactic biopsy

    1 week after surgical procedure

Study Arms (1)

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 imagingDiagnostic Test: Cerebral biopsy

Interventions

MRI imagingDIAGNOSTIC_TEST

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

Included patients
Cerebral biopsyDIAGNOSTIC_TEST

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

Included patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Adult patients, undergoing stereotactic biopsy for newly diagnosed PSNCLs

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele Scientific Institute

Milan, Milan, 20132, Italy

RECRUITING

Related Publications (9)

  • 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: 31632903BACKGROUND

  • 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: 19729544BACKGROUND

  • 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.

    PMID: 33560416BACKGROUND

  • 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: 30344041BACKGROUND

  • 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: 23091408BACKGROUND

  • 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.

    PMID: 29018053BACKGROUND

  • 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: 26895208BACKGROUND

  • 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: 18224529BACKGROUND

  • 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.

    PMID: 23851210BACKGROUND

Study Officials

  • Pietro Mortini, MD, Prof.

    IRCCS San Raffaele Scientific Institute

    STUDY DIRECTOR

Central Study Contacts

Laura Sincinelli

CONTACT

+390226435568sincinelli.laura@hsr.it

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head of Department

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 16, 2024

Study Start

October 1, 2021

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Last Updated

June 11, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)