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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06263361

Enrollment

Registered

2024-02-16

Start date

2021-10-01

Completion date

2029-12-31

Last updated

2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Lymphoma

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.

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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
MRI imaging	Baseline (before surgery)	Peritumoral area (PTA) volumes in T1w sequence Units: cm3.
Define immunopathological features	1 week after surgical procedure	Number of immune cells infiltrating the lesion. Units: number/mm3

Secondary

Measure	Time frame	Description
Accuracy of fluoresceine guided stereotactic biopsy	1 week after surgical procedure	Number of patients with samples positively stained with fluoresceine. Units: number of samples/patients

Countries

Italy

Contacts

Primary ContactLaura Sincinelli

sincinelli.laura@hsr.it+390226435568

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026