跳至主要内容
临床试验/NCT00380666
NCT00380666撤回不适用

The Utility of PET/CT in the Planning of Stereotactic Body Radiotherapy for Non-small Cell Lung Cancer

University of Aarhus0 个研究点开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
主要终点
Concordance indices between CT-based and PET/CT-based target definitions versus volumes of surgical specimens

研究概览

简要总结

The trial evaluates the utility of 18FDG-PET/CT scan in the target definition process when SBRT is planned for stage I NSCLC.

详细描述

The trial aims to evaluate the utility of 18FDG-PET/CT in SBRT planning for NSCLC with particular emphasis on the definition of macroscopic and microscopic boundaries of malignant growth. Studies indicate that the definition of the gross tumor volume may gain in quality when CT and 18FDG-PET are combined. In about 30-60% of NSCLC patients considered for radiotherapy, alteration of CT-based treatment volumes is the consequence of a supplementary 18FDG-PET scan. Studies examining the effect of combined PET/CT scans on the delineation of the GTV generally show reduced intra- and inter-clinician variability. Whether this higher degree of consistency is an actual improvement remains to be proven. Pathological specimens from operated NSCLC patients may serve as a gold standard in this respect. To meet the need for tight margins, the clinical target volume in SBRT planning is generally presumed to correspond to the GTV. Whether this clinical practice rests on firm ground is also an issue that can be addressed in a PET-CT-pathology correlation study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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 or above
  • Histologically or cytologically verified NSCLC
  • Disease stage I (T1-2 N0 M0)
  • Referred from the multi-disciplinary lung cancer conference at Aarhus University Hospital for operation at Skejby Hospital, Aarhus University Hospital
  • Oral and written informed consent

排除标准

  • Medically treated diabetes mellitus
  • Fasting blood-glucoses above 6,7 mM
  • Blood-creatinin above normal
  • Allergies to intravenous contrast
  • Detention according to the Danish laws on psychiatrics that does not comply with participation in a clinical trial
  • Employment at the Dept. of Oncology, Aarhus University Hospital
  • Pregnancy
  • Lactation

结局指标

主要结局

Concordance indices between CT-based and PET/CT-based target definitions versus volumes of surgical specimens

时间窗: 1 month

次要结局

  • Intra- and inter-individual variability of target definition(1 month)

研究者

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

Morten Høyer

Consultant

University of Aarhus

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