IRCCS San Raffaele Scientific Institute
Milan, 20132, Italy
Location status: Recruiting
Recruiting
NCT Number: NCT06263361
Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma.
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
MRI imaging
Diagnostic TestTo characterize the peritumoral area in PCNLs through the use of advanced MRI sequences.
Cerebral biopsy
Diagnostic TestTo evaluate the predictive value of sodium fluorescence to confirm ex-vivo the diagnostic tumor tissue prior to histopathological examination.
Primary outcomes
-
MRI imaging
Time frame: Baseline (before surgery)
Peritumoral area (PTA) volumes in T1w sequence Units: cm3.
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MRI imaging
Time frame: Baseline (before surgery)
Peritumoral area (PTA) volumes in T2w sequence. Units: cm3.
-
MRI imaging
Time frame: Baseline (before surgery)
Peritumoral area (PTA) volumes in FLAIR sequence. Units: cm3.
-
MRI imaging
Time frame: Baseline (before surgery)
Peritumoral area (PTA) mean ADC value in PTA. Units: mm2/s
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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
Time frame: 1 week after surgical procedure
Number of patients with samples positively stained with fluoresceine. Units: number of samples/patients
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
IRCCS San Raffaele
Other
Registry information
Official study title
Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma (PCNSL): Integration of Advanced MRI Patterns and Fluorescein Sodium Fluorescence
Important dates
- Study start
- 2021
- Primary completion
- 2028
- Study completion
- 2029
- First posted
- Feb 16, 2024
- Registry last updated
- Jun 11, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.