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临床试验/NCT04931875
NCT04931875Unknown不适用

Total-body 18F-FDG PET / CT in the Evaluation of Treatment and Prognosis of Patients With Lymphoma

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年10月11日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
OS

研究概览

简要总结

The prospective study aims to explore the value of total-body PET/CT dynamic imaging (uExplorer) in assessing the treatments and prognosis in patients affected with lymphoma. Total-body 18F-FDG PET/CT scans are being performed before treatment, after three cycles of chemotherapy and six weeks after the end of treatment. The plan of this study involves to evaluate the clinical application of total-body PET / CT in patients histopathologically-diagnosed as lymphoma, and to optimize the dynamic acquisition protocols with total-body 18F-FDG PET/CT.

详细描述

100 cases of lymphoma patients are enrolled in this study. Participation in this study involves three dynamic 18F-FDG PET/CT exams, which occur before the treatments start, two or three days before the fourth cycle of chemotherapy, and then six weeks after the end of last treatments. Progress Free Survival(PFS) and Overall Survival(OS) are used as the end points to study the value of metabolic parameters obtained from the dynamic PET/CT imaging. The differences of dynamic metabolic parameters and static SUV value are evaluated in patients with lymphoma from the perspective of diagnosis, staging, treatment and prognosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Provision of signed, written and dated informed consent prior to any study specific procedures
  • Had histologically confirmed lymphoma
  • Patients aged 18~75 years old

排除标准

  • Female patients who are pregnant, breast-feeding
  • Currently active second malignancy other than Lymphoma
  • Any situation not suitable for this study judged by researchers

结局指标

主要结局

OS

时间窗: three years after last patient recruited

The duration from the date of random assignment to the date of death from any cause or censored at the date of the last follow-up.

PFS

时间窗: three years after last patient recruited

Progress-free survival is calculated from the date of randomization to the date of the first progress at any site or death from any cause or censored at the date of the last follow-up.

次要结局

未报告次要终点

研究者

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

Yumei Chen

deputy head of the department of nuclear medicine

RenJi Hospital

研究点 (1)

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