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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06263361
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

IRCCS San Raffaele
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Pietro Mortini, MD, Prof.
Principal Investigator Affiliation IRCCS San Raffaele Scientific Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cerebral Lymphoma
Additional Details

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.

Arms & Interventions

Arms

: 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).

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

IRCCS San Raffaele Scientific Institute, Milan, Italy

Status

Recruiting

Address

IRCCS San Raffaele Scientific Institute

Milan, , 20132

Site Contact

Laura Sincinelli

[email protected]

003926435568

Stay Informed & Connected