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临床试验/NCT01865058
NCT01865058Unknown不适用

The Use of 18 F-FDG Positron Emission Tomography (PET) in the Early Response Evaluation of Diffuse Large B-cell Lymphoma.

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Progression free survival

研究概览

简要总结

Non-Hodgkin lymphoma (NHL) is one of the more frequent cancers in the western world with approx. 800 new cases annually in Denmark. Diffuse large B-cell lymphoma (DLBCL) in Denmark accounts for almost 40% of newly diagnosed NHL cases. Treatment with the combination of chemotherapy and monoclonal antibodies has significantly improved prognosis over the past decade, but a large proportion of patients with DLBCL will continue to relapse with our current treatment options. Therefore, there is a need for reliable methods for detection of treatment response as early as possible in the treatment course in order to identify patients who respond poorly to standard treatment and potentially would benefit from a change in treatment strategy. This has still not been established, but a valid early marker is required in order to allow randomized trials of treatment stratified by early response. One of the most promising applications of PET is the metabolic assessment of the early response of cancer treatment.

This study is a national prospective multicenter study emanating from the Danish Lymphoma Group (DLG). Patients are scanned after each of the early 4 cycles of chemo therapy. The aim is to establish the correct timing of response evaluation. Additionally, the investigators wish to investigate the optimal qualitative and quantitative method of response assessment in order to predict post-therapeutic remission and long-term prognosis.This study will contribute to interim-PET being implemented in the most optimal way in daily clinical practice.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age>18 years

排除标准

  • Previously treatment with chemotherapy or irradiation
  • Primary CNS lymphoma
  • Recurrent lymphoma
  • Transformation from indolent lymphoma
  • Presence of diabetes mellitus, HIV, chronic inflammatory disease or infections
  • Planned for curative treatment

结局指标

主要结局

Progression free survival

时间窗: 3 years

次要结局

  • Overall survival(2 years, 3 years)

研究者

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

Karen Juul Mylam

MD

Odense University Hospital

研究点 (1)

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