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临床试验/NCT01552655
NCT01552655已完成不适用

Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2011年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
2
主要终点
Diagnostic value of dual-time point 18FDG PET/CT in recurrent breast cancer

研究概览

简要总结

The purpose of this study is to elucidate the value of dual-time-point PET/CT in the recurrence of breast cancer and to determine whether the method is better than the modalities used in the standard work up.

150 patients with suspected breast cancer recurrence will be included. All patients will undergo dual-time-point PET/CT, CT of thorax and upper abdomen and bone scintigraphy. After completion of the examinations the early and the late PET/CT scan will be compared with each other, the diagnostic CT-scan and the bone scintigraphy. A verification of suspicious findings will be done by biopsy, if the area is accessible. If a biopsy cannot be obtained, the presence of recurrence will be verified with additional imaging follow-up to ensure the highest possible confidence. Sensitivity, specificity, accuracy, negative and positive predictive value (NPV/PPV) will be calculated for each modality (incl. early and late PET/CT).

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
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Clinical suspected recurrence of breast cancer
  • Blood glucose level less than 8,0 mmol/L

排除标准

  • Disqualified patients
  • Other malignancies
  • < 18 years
  • Pregnant or lactating
  • Patients with permanent address outside of the Region of Southern Denmark
  • Estimated inability to collaborate

结局指标

主要结局

Diagnostic value of dual-time point 18FDG PET/CT in recurrent breast cancer

时间窗: 2 years

The sensitivity and specificity of dual-time point 18FDG PET/CT will be compared to conventional imaging modalities usually used in the work up of patients with suspected recurrent breast cancer. In this case CT of thorax and upper abdomen and bone scintigraphy.

次要结局

  • Diagnostic value of early and late 18FDG PET/CT respectively in recurrent breast cancer(2 years)

研究者

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

Kirsten Falch

Medical Technologist

Odense University Hospital

研究点 (2)

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