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临床试验/NCT05083936
NCT05083936Unknown不适用

Prospective Comparison of 18F-FDG and 18F-FET PET for Response Evaluation in Patients With Primary Central Nervous System Lymphoma

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年8月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Change of target to background ratio between baseline, mid-therapy and end-of treatment PET in patients with primary central nervous system lymphoma

研究概览

简要总结

The overall goal of this imaging trial is to prospectively compare the usefulness of 18F-FDG PET and 18F-FET PET in evaluating treatment response and predicting prognosis in patients with central nervous system lymphoma.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • In order to be eligible for participation in this trial, the subject must:
  • Be ≥ 19 years of age.
  • Patients diagnosed with central nervous system lymphoma by surgery/biopsy or suspected of central nervous system lymphoma by anatomical imaging examination such as MRI.
  • Patients who have results or are planning to examine 18F-FDG PET in the above patients.

排除标准

  • The subject must be excluded from participating in the trial if the subject fulfil any single criteria described below:
  • Pediatric and adolescent patients under 19 years of age.
  • The patient is pregnant, is attempting to become pregnant, or is nursing (breast-feeding) to children.
  • Patients with diagnosed or suspected lymphoma lesions in organs other than the cetral nervous system.
  • Based on the investigator's judgement, if the patient makes it impossible to collect complete data for a clinical trial due to personal or other reasons.
  • Patients who cannot stably have PET/CT due to claustrophobia, dyskinesia, anxiety disorder, seizure, etc.
  • Based on the investigator's judgement, if the patient has a serious and/or uncontrolled and/or unstable medical disease (e.g., congestive heart failure, acute myocardial infarction, severe lung disease, chronic renal disease or chronic liver disease, etc.)

研究组 & 干预措施

[18F]FET PET

Experimental

干预措施: [18F]FET (Drug)

结局指标

主要结局

Change of target to background ratio between baseline, mid-therapy and end-of treatment PET in patients with primary central nervous system lymphoma

时间窗: 20-40 minutes post injection

次要结局

  • 1.5 year progression free survival(18months)

研究者

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

Minyoung Oh

Assistant professor

Asan Medical Center

研究点 (1)

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