A Prospective Cohort Study to Evaluate the Impact of Preoperative Breast Magnetic Resonance Imaging (MRI) on Surgical Decision-Making in Young Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 44
- 试验地点
- 4
- 主要终点
- Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer
研究概览
简要总结
Young women with breast cancer have an increased breast tissue density and conventional imaging tests such as mammography and breast ultrasound are less sensitive and specific for detecting breast cancer than in older breast cancer patients. Breast MRI is an emerging tool that has been proven to improve the ability to identify breast cancers by determining the extent of disease and also detect multifocal, multicentric and bilateral breast cancers. To date, the role of pre-operative breast MRI is not clearly defined. The investigators are proposing a study to evaluate the impact of preoperative breast MRI on surgical decision-making in breast cancer patients <= 50 years. This may lead to improved characterization of breast cancers in these younger patients that may ultimately result in lower local recurrence rates in the future. The additional information attained through the breast MRI may also guide the use of radiation, chemotherapy and/or hormonal therapy in these patients.
详细描述
Inclusion Criteria:
- female aged ≤ 50
- histologically proven invasive breast cancer
Exclusion Criteria:
- Is not considered a surgical candidate
- Has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed lesion
- Has a contraindication to undergoing breast MRI
- Has inflammatory breast cancer according to the standard clinical definition
- Has locally advanced breast cancer according to the standard clinical definition
- Patient is pregnant
- Has a psychiatric or addictive disorder that would preclude obtaining informed consent or adherence to the protocol
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged <= 50 years
- •Histological proof of invasive breast cancer via fine needle aspiration or core needle biopsy
- •Premenopausal
排除标准
- •Patient not considered an appropriate surgical candidate; i.e., patient is not well enough to have breast cancer surgery
- •Patient has had prior breast cancer surgery or an excisional biopsy of the newly diagnosed cancer
- •Patient has a contraindication to undergoing breast MRI (i.e., pacemaker, neurodefibrillator, metallic foreign bodies, etc.)
- •Patient has inflammatory breast cancer according to the standard clinical definition. This is a type of breast cancer in which there is evidence of erythema and/or edema. The skin of the breast may also have changes of peau d'orange.
- •Patient has locally advanced breast cancer according to the standard clinical definition.
- •Patient is pregnant
- •Patient has a psychiatric or addictive disorder that would preclude them from obtaining informed consent.
结局指标
主要结局
Does pre-operative magnetic resonance imaging (MRI) effect surgical management in young women with breast cancer
时间窗: 3 months
次要结局
- Proportion of patients requiring a second surgery due to positive tumour margins.(3 months)
- Incidence of multifocal or multicentric or bilateral breast cancer found on MRI(After surgery)
- The correlation between MRI tumour size and the pathologic tumour size after surgery.(3 months)