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临床试验/NCT03051568
NCT03051568Unknown不适用

Evaluating Fluorine-18 Fluorodeoxyglucose Positron Emission Tomography /Computed Tomography With Liver SUVmax-based Criteria for Prognosis of Patients With Peripheral T-cell Lymphoma

Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Change from baseline in summed standardized uptake value (SUVmax) of lesion after 2 or 4 cycles

研究概览

简要总结

The purpose of this study is to evaluate whether a semi-quantitative interpretation using the liver SUVmax as reference can better interpret 18F-FDG PET/CT and predict disease progression during chemotherapy or survival in PTCL.

详细描述

In this study investigators develope a semi-quantitative interpretation using the liver SUVmax as reference to interpret 18F-FDG PET/CT. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold or new 18F-FDG avid lesions. Investigators compare the prognostic accuracy of the liver SUVmax-based criteria with the 5-PS criteria and ΔSUVmax interpretation with respect to predicting disease progression during chemotherapy or survival in PTCL. Furthermore,investigators improve the prognostic ability of interim PET/CT by comparing the results to the clinical prognostic factors.

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
12 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •newly diagnosed PTCL
  • •treated using an anthracycline-containing regimen
  • •minimal follow-up at 6 months after the completion of first-line treatment
  • •complete medical history and clinicopathological data

排除标准

  • •secondary malignant disease
  • •serious infection or inflammation (e.g., HIV)
  • •primary central nervous system lymphoma
  • •hepatic or renal dysfunction.

研究组 & 干预措施

PTCL patients with 18F-FDG PET/CT

Experimental

18F-FDG PET/CT scans is to be evaluated using liver SUVmax-based criteria, Deauville 5-point criteria and reduction of SUVmax criteria

干预措施: 18F-FDG PET/CT (Device)

结局指标

主要结局

Change from baseline in summed standardized uptake value (SUVmax) of lesion after 2 or 4 cycles

时间窗: baseline(diagnosed by pathology and before chemotherapy) and 2 or 4 cycles after starting chemotherapy (each cycle 21days)

次要结局

  • 3 year progression-free survival(up to 3 years after initial diagnosis)

研究者

发起方
Peking University Cancer Hospital & Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xuejuan Wang,MD

Principal Investigator

Peking University Cancer Hospital & Institute

研究点 (1)

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