PET Imaging of Breast Cancer Using Oncogene Expression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 19
- 主要终点
- Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog
研究概览
简要总结
This clinical trial studies positron emission tomography imaging in using copper Cu 64 TP3805in patients with breast cancer. Diagnostic procedures, such as positron emission tomography (PET) and positron emission mammography (PEM) scan, using Cu-64-TP3805 may help doctors find and diagnose breast cancer.
详细描述
OBJECTIVES:
I. The study's primary goal is to assess the ability of Cu-64-TP3805 (copper Cu 64 TP3805) to detect primary breast lesions as determined by the F-18-FDG (fludeoxyglucose F 18) scan.
II. The study's second goal is to determine the ability of Cu-64-TP3805 to detect primary breast lesions as determined by histology (sensitivity).
III. The study's third goal is to determine the ability of Cu-64-TP3805 to detect metastatic lesions as identified by the F-18-FDG whole-body scan.
OUTLINE: This is a dose-finding 2-stage study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 cancer shown with abnormal mammogram and histology verification (stage-1 patients will also need to have a positive F-18-FDG whole-body scan)
- •Tumor mass of 1 cm or larger, as determined by mammography, ultrasound, or magnetic resonance imaging (MRI)
- •Signed informed consent form approved by the institutional review board (IRB)
排除标准
- •Pregnant or lactating female
- •Patient with asthma
研究组 & 干预措施
F-18-FDG Whole body Scan
STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.
干预措施: Positron Emission Mammography (Device)
F-18-FDG Whole body Scan
STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.
干预措施: Fludeoxyglucose F-18 (Radiation)
F-18-FDG Whole body Scan
STAGE I: Patients with a positive biopsy and abnormal (positive) fludeoxyglucose F18-labeled PET whole-body scan undergo a whole-body copper Cu 64 TP3805-labeled PET scan.
干预措施: Copper Cu 64 TP3805 (Drug)
No F-18-FDG Scan
STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.
干预措施: Positron Emission Tomography (Device)
No F-18-FDG Scan
STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.
干预措施: Fludeoxyglucose F-18 (Radiation)
No F-18-FDG Scan
STAGE II: Patients with a positive biopsy, but no fludeoxyglucose F18 scan undergo a breast fludeoxyglucose F18-labeled PEM Positron Emission Mammography scan followed by a breast copper Cu 64 TP3805-labeled PEM scan.
干预措施: Copper Cu 64 TP3805 (Drug)
结局指标
主要结局
Number of F-18-FDG Positive Lesions That Are Detected by the Copper Cu 64 TP3805 Analog
时间窗: 4 hours after Cu 64 TP3805 administered
Cu-64 results will be compared with those of F-18-FDG for: The unit of analysis will be the lesion (with potentially multiple lesions available per patient).
次要结局
- Ability of Copper Cu 64 TP3805 to Detect Primary Breast Lesions as Determined by Histology (Sensitivity)(4 hours after Cu 64 TP3805 administered)