跳至主要内容
临床试验/NCT06263361
NCT06263361招募中不适用

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

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
15
试验地点
1
主要终点
MRI imaging

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients, undergoing stereotactic biopsy for newly diagnosed PSNCLs

排除标准

  • Severe hepatic dysfunction
  • Severe renal dysfunction
  • Severe heart failure
  • myocardial infarction and stroke within 90 days
  • Hyperreactivity against contrast agents
  • Pregnancy

结局指标

主要结局

MRI imaging

时间窗: Baseline (before surgery)

Peritumoral area (PTA) mean ADC value in PTA. Units: mm2/s

Define immunopathological features

时间窗: 1 week after surgical procedure

Number of immune cells infiltrating the lesion. Units: number/mm3

次要结局

  • Accuracy of fluoresceine guided stereotactic biopsy(1 week after surgical procedure)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Pietro Mortini, MD, Prof.

Professor, Head of Department

IRCCS San Raffaele

研究点 (1)

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