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

Recruiting

• Conditions: Cerebral Lymphoma
• Interventions: Diagnostic Test: MRI imaging; Diagnostic Test: Cerebral biopsy

• Registration Number: NCT06263361
• Lead Sponsor: IRCCS San Raffaele

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.

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2024-01-30
• Status Verified: 2024-02
• Study First Submitted QC: 2024-02-08
• Last Update Submitted: 2024-02-08
• Study First Posted: 2024-02-16
• Last Update Posted: 2024-02-16
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Included patients	MRI imaging	Adult patients (\>18 years) candidates to stereotactic biopsy for histopathological diagnosis of intra-axial lesions suspected for primary central nervous system lymphoma (PCNSLs).
Included patients	Cerebral biopsy	Adult patients (\>18 years) candidates to stereotactic biopsy for histopathological diagnosis of intra-axial lesions suspected for primary central nervous system lymphoma (PCNSLs).

Primary Outcome Measures

Name	Time	Method
MRI imaging	Baseline (before surgery)	Peritumoral area (PTA) mean ADC value in PTA. Units: mm2/s
Define immunopathological features	1 week after surgical procedure	Number of immune cells infiltrating the lesion. Units: number/mm3

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IRCCS San Raffaele Scientific Institute; 🇮🇹 Milan, Italy