Monitoring Treatment Response in Women With Breast Cancer Utilizing FLT-PET/CT
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Sensitivity and specificity of FLT-PET comparing with standard FDG-PET
研究概览
简要总结
This study will investigate the sensitivity and specificity of FLT-PET/CT in primary breast cancer detection and in the use of FLT-PET in monitoring how well a breast tumor respond to treatment. We will compare this technique with other imaging modalities as well as with tissue collection (during a biopsy). We will recruit women with a newly diagnosed invasive breast cancer, who are able to tolerate undergoing a PET/CT (possibly two scans) scan,
详细描述
Our overall goal is to use this clinical trial as a platform to validate fibroblast activation protein (FAP) as a biomarker for the tumor microenvironment and to explore the dynamic interaction between proliferating tumor cells and the tumor microenvironment. Our long term goal is to develop new drugs that will target the tumor microenvironment as novel therapeutic and chemoprevention strategies.
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
- None
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
- •Breast biopsy positive for an invasive malignancy (core needle, mammatone, or incisional biopsy)
- •Participants must be planning to have surgery at the Hospital of the University of Pennsylvania
- •Participants must be able to tolerating lying on the table for about an hour
- •Newly diagnosed primary breast cancer, which is classified as being operable (T1-T4)
排除标准
- •Pregnant women
- •History of severe renal disease
- •Prior history of breast cancer of the study breast within the last five years.
结局指标
主要结局
Sensitivity and specificity of FLT-PET comparing with standard FDG-PET
Correlate SUV with % Ki67 nuclear stain
次要结局
- Change in SUV with change in tumor proliferation index (%Ki67 nuclear stain) (when neoadjuvant therapy is used)
- Tumor volume pre and post chemotherapy as assessed by clinical exam, breast imaging studies, histopathological examination, and breast cancer outcome parameters (when neoadjuvant therapy is used)