Molecular Breast Imaging: Evaluation of a New Technique Using Scintimammography as an Additional Diagnostic Tool for Women Presenting With a History of Bloody Nipple Discharge and Negative Routine Imaging Studies - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Detection of Breast Cancer
研究概览
简要总结
The purpose of this study is to evaluate molecular breast imaging in the workup of patients with a history of bloody nipple discharge, not reproducible in the office who have a negative clinical breast examination, and a negative diagnostic mammogram and breast ultrasound.
详细描述
Although the cause of bloody nipple discharge is benign in most cases, the evaluation is focused on excluding a malignant cause. When bloody nipple discharge is clinically reproducible, management traditionally involves surgical duct excision. When bloody nipple discharge is not reproducible and mammogram and ultrasound are negative the management relies on "watchful waiting" - serial breast imaging to exclude a focal finding and continued observation for recurrent bloody nipple discharge. This approach provokes anxiety among patients who do not have a clear explanation for the bloody nipple discharge. Galactography is useful when positive, but has a high false-negative rate. MRI has not been studied in this context and is costly. Ductoscopy may play a diagnostic role in the future, but experience and equipment are limiting variables. The availability of a less costly method of excluding breast cancer would be of great value in this population.
Molecular Breast Imaging (MBI) is a highly promising novel methodology for breast cancer detection developed under the leadership of Dr. Michael O'Connor at Mayo Clinic, Rochester, MN. Preliminary patient studies with our dual-detector system indicate that this system is capable of reliably detecting very small (5-10 mm) malignant lesions in the breast.
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
- 25 Years 至 75 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women age 25 - 75
- •Women with a negative diagnostic mammogram and ultrasound
- •Women with a history of bloody nipple discharge which can not be reproduced by the examining physician or the patient in the office
排除标准
- •Pregnant or lactating
- •Unable to understand or sign a consent form
- •Physically unable to sit upright and still for 40 minutes
结局指标
主要结局
Detection of Breast Cancer
时间窗: 6 Months
次要结局
未报告次要终点
研究者
Dietlind Wahner-Roedler
Principal Investigator
Mayo Clinic
