NCT01869335Unknown不适用
A Randomized Study Comparing ex Vivo MRI Versus Radiography of Breast Specimens in Evaluating Tumor-free Margins After Surgical Resection of Breast Microcalcifications
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano2 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2013年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Diagnostic efficacy of Magnetic Resonance Imaging (MRI) versus radiography in evaluating tumor-free margins in breast cancer specimens
研究概览
简要总结
Radiography of breast specimens is currently the only radiological procedure used to verify removal of microcalcifications and presence of tumor-free margins after breast surgical resection. Ex vivo MRI will be tested for its ability to detect residual tumor tissue not detected by radiography in resected breast tumor specimens and/or its ability to verify tumor-free margins in breast cancer detected by MRI only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- 否
入选标准
- •Women with malignant breast disease identified by microcalcifications without clinically evident disease
- •Women candidate to breast preserving surgery
排除标准
- •Cardiac pacemaker, defibrillators, cardiac monitors
- •Brain stimulators, implantable spinal stimulators
- •Vascular and aneurismal clips
- •Hemostatic clips
- •Infusion pumps
- •Glaucoma drainage implants
- •Metallic foreign body positioned in vital organ of the patients
- •Some heart valves
- •Some vascular access ports, infusion pumps and catheters
- •Permanent contraceptive tubal device
- •Kidney disease
结局指标
主要结局
Diagnostic efficacy of Magnetic Resonance Imaging (MRI) versus radiography in evaluating tumor-free margins in breast cancer specimens
时间窗: 2 years
Diagnostic efficacy will be evaluated by statistical analysis
次要结局
未报告次要终点
研究者
Roberto Agresti, MD
MD
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
研究点 (2)
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