NCT01687790已完成不适用
The Assessment of Molecular Breast Imaging (MBI) in Distinguishing Benign From Malignant Breast Disease.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.
研究概览
简要总结
The primary hypothesis of this project is that using molecular breast imaging (MBI) in evaluating women with equivocal mammographic or sonographic findings will demonstrate high specificity in distinguishing benign from malignant breast disease and, as a result, decrease the number of biopsies.
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
- 否
入选标准
- •18 years of age or older
- •Women who have indeterminate mammographic or sonographic findings who are recommended and for biopsy
排除标准
- •Known contraindication to mammographic imaging
- •women who are pregnant
- •women who are lactating
- •women who have significant existing breast trauma
- •women who have breast implants
- •Women under 18 years of age.
- •women who had previous benign breast surgery within 1 year
- •Males and children
- •Women who are unable to understand or execute written informed consent
- •Women who refuse to have a biopsy
- •Women with any known renal disease - if an MRI is deemed necessary, a serum creatine will be checked prior to injection of contrast. Using the National Kidney Foundation recommendations, a glomerular filtration rate (GFR) greater than 60 may safely receive intravenous gadolinium-based MRI contrast. Those individuals with a GFR >30 and <60 can receive the contrast but at a reduced dose (typically half). Those with a GFR <30 will not receive MRI contrast and will not undergo the exam. Breast MRI must be done with contrast if evaluating for cancer. Several factors can affect the GFR such as age, body size, creatinine, renal status and will be calculated from the blood drawn. GFR is the final determinant and a creatinine greater than 1.6 usually has a GFR that precludes a Breast MRI with contrast. The final determinant will be the GFR.
结局指标
主要结局
Specificity of MBI. Specificity is Defined as the Number of True Negatives/ Total Number of Negative Pathology Results.
时间窗: 1 year
The number of indeterminate lesions with negative MBI uptake and negative/benign pathology results.Reported are number of indeterminate lesions with negative MBI uptake and negative/benign pathology results (true negatives).
次要结局
- Sensitivity of MBI. Sensitivity in This Case is Defined as the Number of True Positives/ Total Number of Positive Pathology Results.(1 year)
研究者
Christiane Hakim
Principal Investigator
University of Pittsburgh
研究点 (2)
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