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Trial Title:
Improving Safety and Accuracy of Stereotactic Brain Biopsies in Primary Central Nervous System Lymphoma.
NCT ID:
NCT06263361
Condition:
Cerebral Lymphoma
Conditions: Official terms:
Lymphoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
MRI imaging
Description:
To characterize the peritumoral area in PCNLs through the use of advanced MRI sequences.
Arm group label:
Included patients
Intervention type:
Diagnostic Test
Intervention name:
Cerebral biopsy
Description:
To evaluate the predictive value of sodium fluorescence to confirm ex-vivo the diagnostic
tumor tissue prior to histopathological examination.
Arm group label:
Included patients
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.
Criteria for eligibility:
Study pop:
Adult patients, undergoing stereotactic biopsy for newly diagnosed PSNCLs at our
Institution, able to express informed consent.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCS San Raffaele Scientific Institute
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Laura Sincinelli
Phone:
003926435568
Email:
sincinelli.laura@hsr.it
Start date:
October 1, 2021
Completion date:
December 31, 2026
Lead sponsor:
Agency:
IRCCS San Raffaele
Agency class:
Other
Source:
IRCCS San Raffaele
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06263361
