Contrast-Enhanced Digital Mammography(CEDM) vs Contrast-Enhanced Breast MRI(CE-MRI) in Breast Cancer
Contrast-Enhanced Digital Mammography (CEDM) vs Contrast-Enhanced Breast MRI (CE-MRI) in Patients With Known Breast Cancer
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
联系人和位置
学习地点
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California
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Stanford、California、美国、94305
- Stanford University School of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Identify inclusion criteria
- Histologically confirmed invasive and/or in situ carcinoma of the breast
- Any race and ethnicity
- Females 18-70 years of age
- Willing and able to provide informed consent
- Subject will have a CE-MRI exam within one month (31 days) of enrolling or has had a CE-MRI exam within one month (31 days) prior to enrolling with no interval treatment or procedure between the CEDM and CE-MRI
Identify exclusion criteria
- Unwilling or unable to undergo informed consent
- Planned to undergo neoadjuvant chemotherapy
- Breast implants
- Pregnant (NOTE: If subject is unsure of pregnancy status, a pregnancy test will be performed for confirmation.)
- Breast-feeding
- Surgical excision of the biopsy proven malignancy
- Known allergy to gadolinium contrast agents
- Contraindication for MRI (ex: pacemaker, ferromagnetic aneurysm clips or other ferromagnetic surgical implant or severe claustrophobia)
Suspected to be at risk to complications from the contrast agent. These include the standard iodinated contrast agent contraindications:
- Subject has renal insufficiency as determined by an elevated serum creatinine and is not being treated with dialysis.
- Documentation of a normal eGFR (MDRD) within the previous 2 months will be required for any subject with any of the following risk factors for renal insufficiency:
i. Age > 70 ii. Diabetes iii. Personal history of renal disease iv. Family history of renal disease (e.g., polycystic kidney disease) v. Known solitary kidney vi. Other medical conditions that may affect the kidney (e.g., Lupus, multiple myeloma) c. Subject has taken metformin (Glucophage) within 48 hours of procedure d. Subject has had a prior reaction to iodinated contrast e. Subject has multiple allergies and/ or severe asthma regularly treated with medication f. Subject has had an episode of serious allergic reaction (anaphylaxis) to any substance
学习计划
研究是如何设计的?
设计细节
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Number of partipicants with adverse events
大体时间:up to 24 weeks
|
up to 24 weeks
|
合作者和调查者
调查人员
- 首席研究员:Jafi Lipson、Stanford University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- BRS0031
- 27277
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