Comparison of Magnetic Resonance Imaging and Molecular Breast Imaging in Breast Diagnostic Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Sensitivity on the Per Patient Level
研究概览
简要总结
The purpose of this study is to determine the sensitivity of Molecular Breast Imaging (MBI) relative to MRI of the breast in patients undergoing MRI for a clinical concern, or abnormal diagnostic mammogram and/or ultrasound study.
详细描述
Background: Breast MRI has excellent sensitivity, but is very expensive and suffers from low specificity. Additional benign biopsies are prompted by MRI in 24-40% of patients. Molecular Breast Imaging (MBI) is a new nuclear medicine technique developed at Mayo. Preliminary MBI results indicate a sensitivity of ~88% for the detection of tumors < 10 mm. The cost of an MBI procedure is expected to be a factor of 5 less than an MRI examination.
Hypothesis
MBI has a comparable sensitivity to MRI at a significantly lower cost.
Study Design: A total of 120 patients will be studied. All patients will have been scheduled for bilateral breast MRI at Mayo Clinic Rochester for a clinical concern, problem solving, or abnormal mammogram and/or ultrasound study. All patients will undergo MBI within 3 weeks of the MRI examination.
Potential Outcomes: This study will provide valuable information on the sensitivity of MBI relative to MRI, and to determine if this new technique can be eventually developed as an alternative to MRI for problem solving.
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
- Single (Investigator)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •This study will include a population of women aged 25 or older who are scheduled for a breast MRI examination at MAYO CLINIC ROCHESTER.
- •Patients must not be lactating or pregnant.
- •All women of child-bearing potential must have had a negative urine pregnancy test result within 2 days prior to the MBI study.
- •women who are scheduled for a breast MRI examination for a clinical concern, problem solving or for further evaluation of invasive breast cancer (e.g. pre-operative staging of known breast cancer).
排除标准
- •They are unable to understand and sign the consent form
- •They are pregnant or lactating
- •They are physically unable to sit upright and still for 40 minutes.
- •The breast MRI is for screening purposes or to determine the status of breast augmentation.
- •They have undergone breast surgery within the previous year
结局指标
主要结局
Sensitivity on the Per Patient Level
时间窗: within 1 week of surgery or biopsy
Sensitivity is the number of women with breast cancer detected per number of women with breast cancer diagnosed by surgery or biopsy.
次要结局
- Sensitivity on the Per Tumor Level(within 1 week of surgery or biopsy)
- Specificity(at least one year following imaging)