Staging of Axillary Lymph Nodes Using the PEM Flex Solo II Pet Scanner in Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer
研究概览
简要总结
The purpose of this study is to determine if PEM scan can improve axillary lymph node staging by assessing if they are involved by cancer. Your doctor may refer you for a PEM scan, PEM stands for positron emission mammography, a relatively new and advanced application of positron emission tomography or PET scanning. For decades, PET has helped doctors diagnose and treat disease.
详细描述
Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be performed of both the ipsilateral and contralateral breast and axillae by a Mammography Technologist trained in mammographic positioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e. lumpectomy).
排除标准
- •Children (<18 years old)
- •Pregnant or Lactating women
- •Diabetic patients (Type I or II)
- •Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM
- •Patients who have NOT undergone a standard of care bilateral breast MRI at UC.
结局指标
主要结局
Sensitivity and Specificity of FDG Positron Emission Mammography (PEM) in Identifying Axillary Lymph Node (ALN) Metastases From Breast Cancer
时间窗: PEM was performed prior to surgery and LN sampling immediately following surgery
Based on FDG Positron Emission Mammography (PEM) image, a breast region was classified as "normal" or "abnormal". Lymph Node (LN) sampling and histopathology determined true positives and true negatives.
次要结局
未报告次要终点