NCT05990478撤回不适用
Contrast-Enhanced Mammography With Early and Delayed Acquisitions in the Assessment of the Extent of Residual Disease Following Neoadjuvant Treatment in Patients With Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Compare the sensitivity and specificity of Contrast-Enhanced Mammography/CEM with standard 'early' acquisition to CEM with delayed acquisition
研究概览
简要总结
The purpose of this study is to find out whether Contrast-Enhanced Mammography/CEM scans performed 2 minutes and 6 minutes after receiving Iohexol contrast dye can be used to identify the amount of residual disease in the breast following neoadjuvant treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Any women >18 years of age at time of informed consent
- •Diagnosed with breast cancer and schedule for NAT
排除标准
- •History of kidney disease, creatinine level >1.3 or eGFR <
- •Known allergic reaction to gadolinium or iodinated contrast media.
- •Contraindication to contrast-enhanced breast MRI.
- •Lesion not included in the field of view of either pre- or post-NAT MRI or CEM
- •Presence of pacemakers or automated implantable cardioverter defibrilator
- •Pregnant women
结局指标
主要结局
Compare the sensitivity and specificity of Contrast-Enhanced Mammography/CEM with standard 'early' acquisition to CEM with delayed acquisition
时间窗: Up to 1 year
compare the sensitivity and specificity of CEM with standard 'early' acquisition to CEM with delayed acquisition, in detecting breast cancer lesions with pathological complete response (pCR) after NAT.
次要结局
未报告次要终点
研究者
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