Breast Cancer Recurrence - the Accuracy of Dual-time PET/CT
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
- 否
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
Kirsten Falch
Medical Technologist
Odense University Hospital
