Improved Breast Dynamic Contrast Enhanced-magnetic Resonance Imaging (DCE-MRI) With Sweep Imaging With Fourier Transform (SWIFT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Lesions
研究概览
简要总结
Today's medical imaging methods have insufficient specificity for reliable differentiation between benign and malignant breast lesions in patients. Pathologic evaluation is currently the only way to obtain a definitive diagnosis. This research will use a novel method of magnetic resonance imaging (MRI), Sweep Imaging with Fourier Transform (SWIFT), at a very high magnetic field (4 Tesla) to distinguish malignant from benign breast lesions. This research will reveal whether the SWIFT sequence bears new capabilities in medical imaging for breast cancer diagnosis.
详细描述
Patients will be asked to come to the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. Researchers will interview the patient and describe procedures and risks. An intravenous (IV) line will be placed in an upper extremity for infusing magnetic resonance imaging (MRI) contrast dye. Baseline MRI scans will be done. These MRI measurements will be compared with clinical, radiological and pathological findings (the gold standard).
Follow-up contact will occur within one year after the MRI to determine whether a pathology report is available.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with a clinically or mammographically identified suspicious breast mass that is likely to be biopsied or surgically removed.
排除标准
- •Pregnancy
- •Ferromagnetic implants
- •History of shotgun wounds and shrapnel
- •Obesity (>250 pounds)
- •Cardiac pacemaker
- •Incompatible implanted medical device
- •Severe claustrophobia
- •Major surgeries with potential of ferromagnetic implants
- •Severe asthma and allergies
- •i-STAT system, a handheld blood analyzer (I-STAT) creatinine test, estimated glomerular filtration rate (GFR) <30
- •Metallic object (greater than 2 cm in length) in the breast
- •Metallic ink tatoo within 20 cm of the breast (approximately 8 inches)
结局指标
主要结局
Lesions
时间窗: at time of read by two radiologiests, compared to biopsy within 7 days.
Number of lesions detected
次要结局
未报告次要终点