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临床试验/NCT00688337
NCT00688337Unknown不适用

Correlation Between Fluorodeoxyglucose (FDG) and FLT Uptake and Gene-Expression Oncotype Assay in Patients With Breast Cancer

Tel-Aviv Sourasky Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年6月最近更新:
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
Correlation between FDG and FLT uptake and hystological findings and Oncotype results

研究概览

简要总结

In the current study FDG (Fluorodeoxyglucose) uptake, FLT uptake (F18-Fluoro-3'-deoxythymidine) and their ratios will be correlated with the risk score results of the Oncotype gene-expression assay in patients with clinically negative nodal disease planned for surgical removal of the tumor.

详细描述

Several publications have addressed the role of PET imaging for biological characterization of breast cancer. A modest but significant correlation was reported between tumor grading and FDG uptake. Few studies reported a positive correlation between SUV and the Ki-67 labeling index of malignant breast tumors. Others have correlated p53 expression in breast cancer and FDG uptake. F18-Fluoro-3'-deoxythymidine (FLT) has been developed as a PET marker for cellular proliferation has been developed for imaging cell proliferation and findings correlate strongly with the Ki-67 labeling index in breast cancer. A 10-minute FLT-PET scan acquired two weeks after the end of the first course of chemotherapy, has been shown in two recent studies to be useful for predicting longer-term efficacy of chemotherapy regimens for women with breast cancer.

In the current study FDG and FLT uptake and their ratios will be correlated with the risk score results of the Oncotype gene-expression assay in patients with clinically negative nodal disease planned for surgical removal of the tumor. It is our hypothesis that since high uptake of these tracers implies aggressive behavior and rapid tumor growth, it might well be that patients with high risk score on Oncotype will have high uptake of the PET tracers and those with low risk score will show low-intensity uptake values. If this will be the case, it might well be that in patients with non-conclusive oncotype results (intermediate score) FDG and FLT uptake measurement will allow further dichotomy to 1. Patients with intermediate score on Oncotype and high uptake of the PET tracers, suggestive of aggressive behavior and 2. Patients with intermediate score on Oncotype and low uptake of the PET tracers suggesting a less aggressive behavior.

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 86 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Newly diagnosed patients with breast cancer
  • clinically nodal negative
  • prior to surgery and/or treatment
  • age over 18 years

排除标准

  • Age under 18
  • Pregnancy
  • Previous therapy for breast cancer
  • Clinical or histological evidence of nodal involvement or other proven metastatic sites

结局指标

主要结局

Correlation between FDG and FLT uptake and hystological findings and Oncotype results

时间窗: One year after imaging

次要结局

  • Clinical outcome(A year after imaging)

研究者

申办方类型
Other Gov

研究点 (1)

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