Comparison of Breast MRI Versus Contrast Enhanced Mammography Prior to Surgery in Breast Cancer Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Global Costs
研究概览
简要总结
In current clinical practice, women with biopsy proven breast cancer can be sent for breast magnetic resonance imaging (MRI) or contrast enhanced mammography (CEM) prior to surgery in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers. This study seeks to compare the global costs (based on actual reimbursement rates) of CEM/breast MRI, downstream imaging testing, and diagnostic procedures in women randomized to breast MRI versus CEM. Secondary goals are to compare patient preferences for CEM vs MRI and clinically relevant outcomes (e.g. conversion from lumpectormy to mastecomy).
详细描述
This is a pilot randomized controlled trial comparing the global costs of two standard of care imaging techniques in patients with a new breast cancer diagnosis and planned breast conservation surgery. Patients enrolled in this study will be randomized to either CEM or breast MRI. The purpose of this study is to compare the global costs (based on actual reimbursement rates) of initial imaging modality (CEM or breast MRI), downstream imaging related to breast cancer evaluation, and diagnostic breast procedures in women randomized to breast MRI versus CEM.
Secondary endpoints include assessment of patient's reported satisfaction with the initial imaging technique received (CEM versus MRI), quantifying differences in health-related quality of life (as assessed by the patient reported Euro quality of life 5D questionnaire), rate of conversion from planned lumpectomy to mastectomy, and rate of re-operation for positive margins.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Women aged 18 years or older with newly diagnosed breast cancer and planned breast conservation surgery
- •Clinically indicated referral for breast MRI or contrast mammogram prior to surgery
- •Provision of informed consent
排除标准
- •Planned neoadjuvant chemotherapy
- •Patients that are medically unstable
- •Pregnancy
- •Patients with known contraindication to contrast mammography, including:
- •Glomerular filtration rate <30
- •Known adverse reaction to iodinated contrast material
- •Patients with known contraindication to Breast MRI including:
- •Glomerular filtration rate <30
- •Known adverse reaction to gadolinium contrast material
- •Non-MRI conditional device or catheter
- •Brain aneurysm clip implanted before 1995
- •Cochlear implant
- •Ocular foreign body (e.g. metal shavings)
- •Insulin pump
- •Patients unable to read and understand English or Spanish (i.e. an inability to complete study questionnaires)
结局指标
主要结局
Global Costs
时间窗: Through Study Completion (2 years)
The Primary outcome is to compare the global costs (based on actual reimbursement rates) of initial imaging modality (CEM or breast MRI), downstream imaging related to breast cancer evaluation, and diagnostic breast procedures in women randomized to breast MRI versus CEM.
次要结局
- Rate of Conversion(Through Study Completion (2 years))
- Rate of Re-Operation(Through Study Completion (2 years))
- Patient Satisfaction using modified Likert scale(Through Study Completion (2 years))
- Health-Related Quality of Life(Through Study Completion (2 years))
研究者
Michael Morris
Clinical Assistant Professor, Radiology
University of Arizona