Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma (PCNSL): Integration of Advanced MRI Patterns and Fluorescein Sodium Fluorescence
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- MRI imaging
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
MRI imaging
Time Frame: Baseline (before surgery)
Peritumoral area (PTA) mean ADC value in PTA. Units: mm2/s
Define immunopathological features
Time Frame: 1 week after surgical procedure
Number of immune cells infiltrating the lesion. Units: number/mm3
Secondary Outcomes
- Accuracy of fluoresceine guided stereotactic biopsy(1 week after surgical procedure)
Investigators
Pietro Mortini, MD, Prof.
Professor, Head of Department
IRCCS San Raffaele