NCT00874458已完成不适用
Ductal Carcinoma in Situ: Protocol Evaluating the Assessment of Extension of Disease by MRI
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Correlation of tumor extension by MRI with surgical histology
研究概览
简要总结
RATIONALE: Diagnostic procedures, such as MRI, may help find ductal carcinoma in situ and find out how far the disease has spread.
PURPOSE: This clinical trial is studying how well MRI works in assessing tumor size in women with ductal carcinoma in situ.
详细描述
OBJECTIVES:
Primary
- Assess the contribution of MRI in accurately determining tumor size in women with ductal breast carcinoma in situ (DCIS).
Secondary
- Evaluate the sensitivity of MRI in detecting DCIS.
- Evaluate the contribution of mammography in accurately determining tumor size.
- Compare the contribution of MRI vs mammography in assessing tumor extension.
- Compare the contribution of MRI vs mammography in assessing dense breasts.
- Evaluate the morphology of DCIS by MRI.
- Evaluate the curve of dynamic MRI in assessing DCIS.
- Evaluate the impact of nuclear grade of DCIS by MRI.
- Evaluate the rate of revision surgery.
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
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of ductal breast carcinoma in situ
- •Any grade disease allowed
- •Unifocal disease by mammography
- •No history of breast cancer
- •Hormone receptor status not specified
- •PATIENT CHARACTERISTICS:
- •Menopausal status not specified
- •WHO performance status 0-2
- •Glomerular filtration rate ≥ 30 mL/min
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No allergy or contraindication to contrast MRI
- •No pacemaker or vascular clip
- •PRIOR CONCURRENT THERAPY:
- •No prior or concurrent liver transplantation
排除标准
- 未提供
研究组 & 干预措施
MRI
Experimental
干预措施: ultrasound imaging (Procedure)
MRI
Experimental
干预措施: magnetic resonance imaging (Procedure)
MRI
Experimental
干预措施: radiomammography (Procedure)
结局指标
主要结局
Correlation of tumor extension by MRI with surgical histology
时间窗: up to 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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