Metabolic Sodium MRI to Assess Early Response of Breast Cancer to Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in Tumor Size
研究概览
简要总结
Neoadjuvant chemotherapy (NACT) is administered to treat invasive breast cancer before surgery. It offers the opportunity to evaluate tumor response to treatment in aggressive disease, and guide additional therapies for patients with inadequate response, if detected early. Investigators propose to develop a sodium breast MRI technique that will allow to assess the early metabolic response of breast cancer to NACT, occurring before late structural changes can be detected with standard MRI.
This study will scan 12 patients using 1H/23Na MRI at 7 T and DCE MRI with triple-negative breast cancer undergoing AC-T therapy (2 months of Adriamycin + Cyclophosphamide, then 3 months of Taxol): at baseline (pre-NACT); after the first AC cycle (2 weeks); after AC treatment (2 months); after complete NACT (5 months, pre-surgery).
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
- 是
入选标准
- •Women with no sign of breast cancer as controls
- •Non-pregnant and non-lactating
- •Ability to understand and willingness to sign a written consent
排除标准
- •Contra-indications to MRI (i.e., ferromagnetic prostheses, metallic surgical implants that are not compatible with an MRI machine, claustrophobia etc.)
- •Medical condition such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease which, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
- •Pregnant or lactating women, women using hormonal treatment in the 6 months prior to the study.
- •Women with history of breast disease, previous breast surgery, or breast implants.
- •Patients with a currently active second malignancy other than non-melanoma skin cancers. Patients are not considered to have a currently active malignancy if they have completed therapy and are free of disease for 3 years.
- •Psychiatric illness or other conditions and circumstances which could prevent the patient from being compliant with the protocol.
结局指标
主要结局
Change in Tumor Size
时间窗: Baseline, 2 Years
Dynamic contrast-enhanced MRI will be used to measure tumor size before and after treatment.
次要结局
- Intracellular Sodium Concentration (CIC)(Baseline)
- Total Sodium Concentration (TSC)(Baseline)