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临床试验/NCT00286832
NCT00286832已完成不适用

Evaluation of Response to Treatment Using 18F-FDG Positron Emission Tomography Imaging (PET) With Special Emphasize on the Prognostic Significance of Early On-therapy PET at First-line Treatment in Diffuse Large B-cell Lymphoma Stage IIB-IV

Copenhagen University Hospital at Herlev1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2005年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1

研究概览

简要总结

Early identification of refractory lymphoma patients provides a basis for stratification between responders to standard approaches and non-responders who may benefit from an early change to an alternative treatment strategy.Metabolic or molecular imaging with fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET) has emerged as a powerful imaging modality for diagnosis, staging, and therapy monitoring of a variety of cancers. The primary hypothesis of the present study is that early response can be pinpointed by PET reflecting both tumor burden and activity, as a surrogate for final outcome. An increasing number of studies have suggested the potential role of 18F-FDG PET in the staging and monitoring of lymphomas. The optimal timing of PET scans and the potential role of quantitative PET using SUV to assess response to chemotherapy remain to be defined. Confirmation of very early 18F-FDG-PET as a significant predictor of treatment response in a homogenous group of aggressive lymphoma patients would potentially change the prognosis of the patient by allowing earlier use of alternative therapies and discontinuation of therapy that will not lead to a significant tumour response.

详细描述

Title: Evaluation of response to treatment using 18F-FDG positron emission tomography imaging (PET) in diffuse large B-cell lymphoma stage IIB-IV with special emphasize on the prognostic significance of early on-therapy PET at first-line treatment

Study design: Multicenter trial.

Planned sample size: 100 patients.

Number of centers: Denmark 2; Sweden 1; Norway 1; Finland 1.

Aim of the study: 1. To evaluate the prognostic significance of PET early after treatment initiation. 2. To compare early PET with standard response criteria for NHL and the International Prognostic Index (IPI) in the prediction of response and outcome.

研究设计

研究类型
Observational
观察模型
Case Only
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.
  • Newly diagnosed consecutive patients with diffuse large B-cell lymphoma (DLBCL) according to the WHO classification.
  • Ann Arbor stage IIB-IV.
  • Written informed consent.

排除标准

  • Previously treated with chemotherapy or irradiation.
  • Previous malignant diagnosis except basal cell carcinoma and cervical carcinoma in situ.
  • Pregnancy.
  • Lactation.
  • Diabetes mellitus.
  • Extreme adipositas.
  • Claustrophobia.
  • Active inflammatory disease or infection.

研究者

发起方
Copenhagen University Hospital at Herlev
申办方类型
Other

研究点 (1)

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