Histologic Assessment of the Difference Between 18F-2-fluoro-2-deoxy_D-glucose Positron Emission Mammography(PEM) and Magnetic Resonance Imaging (MRI) of the Breast
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- To Evaluate the Accuracy of Preoperative 18FDG PEM
研究概览
简要总结
Positron Emission Mammography (PEM) is a newly developed imaging examination of the breast that uses a radioactive glucose based tracer, which is a form of sugar attached to a low radiation agent, to detect cancer cells. The radioactive glucose based tracer is called fluorodeoxyglucose (FDG), and it is FDA approved. A PEM scanner is able to better detect cancer cells within the breast, more than a regular PET scanner. The PEM scanner is also FDA approved. This type of imaging may be able to see the breast cancer before it could be seen with mammograms and may be as good as or better than breast MRI.
The purpose of this study is to compare the value of FDG Positron Emission Mammography (PEM) with contrast enhanced Magnetic Resonance Imaging (MRI) of the breast for patients with breast cancer. This study will also perform special pathology test to compare the FDG PEM and contrast enhanced breast MRI images with the results from the standard of care breast surgery. This may teach us more about the biology of each breast tumor.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients with recently diagnosed invasive or in situ breast cancer by core needle biopsy or FNA (confirmed at MSKCC) prior to enrollment.
- •Patients planning treatment with mastectomy at MSKCC.
- •Patients 21 years old or older.
- •Patients who had or are having a breast MRI within 30 days or less of PEM.
- •Patients who had or are having a digital mammogram.
排除标准
- •Patients who are pregnant or breast feeding.
- •Patients with prior radiation therapy or endocrine therapy.
- •Patients who had a prior lumpectomy.
- •Patients who are diabetic.
- •Patients with moderate to end stage kidney disease.
- •Patients who have a contraindication to MRI (i.e. pacemaker, metallic implants, etc).
结局指标
主要结局
To Evaluate the Accuracy of Preoperative 18FDG PEM
时间窗: 2 years
using pathology as the gold standard and descriptively compare it to the accuracy of breast MRI in an exploratory analysis which will generate data for future studies. The first 5 patients who consent to the study were used for training purposes only.
次要结局
未报告次要终点