FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- assess the diagnostic accuracy
研究概览
简要总结
This study has been designed to help us determine if FACBC PET or PEM can accurately evaluate how far the breast cancer has spread in the breast. Also, to help determine if FACBC PET or PEM can accurately measure your response to chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Women presenting for evaluation at MSKCC with biopsy proven primary IDC or ILC
- •No prior therapy for IDC or ILC
- •Clinical need for local disease staging with breast MR (Group A only)
- •Clinical need for neoadjuvant chemotherapy (Group B only)
- •Patients must provide written informed consent
排除标准
- •Age <21 years
- •Pregnancy or lactation
- •Patients who have already started treatment for the current malignancy
- •Patients who cannot undergo PET scanning (i.e. because of weight limits)
- •Patients who are known to have contraindication for MRI (e.g. metal implants)
- •Patients may only participate in group #1 or group #2, but not both
研究组 & 干预措施
Local staging patients
Breast MR and FACBC PET/PEM will be scheduled within one week of each other. Breast MR is a standard clinical examination and will be performed as standard.
干预措施: Positron Emission Tomography (PET) (Procedure)
Local staging patients
Breast MR and FACBC PET/PEM will be scheduled within one week of each other. Breast MR is a standard clinical examination and will be performed as standard.
干预措施: Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC) (Drug)
Local staging patients
Breast MR and FACBC PET/PEM will be scheduled within one week of each other. Breast MR is a standard clinical examination and will be performed as standard.
干预措施: Positron emission mammography (PEM) When available (Procedure)
Local staging patients
Breast MR and FACBC PET/PEM will be scheduled within one week of each other. Breast MR is a standard clinical examination and will be performed as standard.
干预措施: MR (Procedure)
Neoadjuvant chemotherapy patients
Baseline FACBC PET/PEM will be scheduled within 1 week of beginning neoadjuvant therapy. A repeat FACBC PET/PEM will be scheduled after the conclusion of neoadjuvant therapy, and before definitive surgical management.
干预措施: Positron Emission Tomography (PET) (Procedure)
Neoadjuvant chemotherapy patients
Baseline FACBC PET/PEM will be scheduled within 1 week of beginning neoadjuvant therapy. A repeat FACBC PET/PEM will be scheduled after the conclusion of neoadjuvant therapy, and before definitive surgical management.
干预措施: Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC) (Drug)
Neoadjuvant chemotherapy patients
Baseline FACBC PET/PEM will be scheduled within 1 week of beginning neoadjuvant therapy. A repeat FACBC PET/PEM will be scheduled after the conclusion of neoadjuvant therapy, and before definitive surgical management.
干预措施: Positron emission mammography (PEM) When available (Procedure)
结局指标
主要结局
assess the diagnostic accuracy
时间窗: 2 years
Accuracy of standardized uptake values will be analyzed by receiver operating characteristic (ROC) curves. ROC curves will be constructed separately for FACBC PET, FACBC PEM and MR. The area under the curve will be used as a summary measure and compared using the standard nonparametric test \[20\]. We will also consider dichotomizing the uptake and present accuracy using sensitivity, specificity and predictive values. Dichotomized values will be compared using the McNemar test.
ability of FACBC PET and PEM to determine therapeutic response to neoadjuvant chemotherapy
时间窗: 2 years
Patients with locally advanced IDC or ILC, requiring neoadjuvant therapy prior to definitive surgery, will undergo FACBC PET and PEM both before chemotherapy and after. Following definitive breast surgery, pathologic specimens will be analyzed to determine if FACBC imaging can predict pathologic treatment response.
次要结局
未报告次要终点