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临床试验/2024-515895-11-00
2024-515895-11-00招募中4 期

Determination Of Molecular Status And Benefit Of Use Fludeoxyglucose (18F-FDG) In PET/CT imagining In Juvenile Patients With Histiocytosis

Instytut Matki I Dziecka1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2024年8月26日最近更新:
相关药物

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
150
试验地点
1
主要终点
EFS – (event-free survival).

研究概览

简要总结

Determination of molecular status and benefit and safety of use fludeoxyglucose (18-FDG) in PET/CT imagening in juvenile patients with histiocytosis.

研究设计

研究类型
Interventional

入排标准

年龄范围
0 years 至 17 years(0-17 Years)
接受健康志愿者

入选标准

  • Patient under 18 years of age at the time of inclusion.
  • Histopatologically confirmed or suspected histiocytosis (based on prior test results).
  • Signing of informed consent for trial participation according with current legal regulations.

排除标准

  • Lack of inclusion criteria.
  • Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the trial.

结局指标

主要结局

EFS – (event-free survival).

EFS – (event-free survival).

次要结局

  • PFS (Progression-Free Survival)
  • OS (Overall Survival)
  • ORR (Overall Response Rate)
  • Reactivation rate after 2 years
  • Rate of participants presenting with Adverse Events separated by degree of intensity, category, affected organ or system.

研究者

发起方
Instytut Matki I Dziecka
申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Klinika Onkologii i Chirurgii Onkologicznej Dzieci i Młodzieży IMID

Scientific

Instytut Matki I Dziecka

研究点 (1)

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