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

June 6, 2025 updated by: Pietro Mortini, MD, Prof., IRCCS San Raffaele

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Milan, Italy, 20132
        • Recruiting
        • IRCCS San Raffaele Scientific Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 imaging
To characterize the peritumoral area in PCNLs through the use of advanced MRI sequences.
Diagnostic test: Cerebral biopsy
To evaluate the predictive value of sodium fluorescence to confirm ex-vivo the diagnostic tumor tissue prior to histopathological examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI imaging
Time Frame: Baseline (before surgery)
Peritumoral area (PTA) volumes in T1w sequence Units: cm3.
Baseline (before surgery)
MRI imaging
Time Frame: Baseline (before surgery)
Peritumoral area (PTA) volumes in T2w sequence. Units: cm3.
Baseline (before surgery)
MRI imaging
Time Frame: Baseline (before surgery)
Peritumoral area (PTA) volumes in FLAIR sequence. Units: cm3.
Baseline (before surgery)
MRI imaging
Time Frame: Baseline (before surgery)
Peritumoral area (PTA) mean ADC value in PTA. Units: mm2/s
Baseline (before surgery)
Define immunopathological features
Time Frame: 1 week after surgical procedure
Number of immune cells infiltrating the lesion. Units: number/mm3
1 week after surgical procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week after surgical procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS San Raffaele

Investigators

  • Study Director: Pietro Mortini, MD, Prof., IRCCS San Raffaele Scientific Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

February 8, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2025

Last Update Submitted That Met QC Criteria

June 6, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCH02-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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