NCT01300585终止不适用
MRI Evaluation to Assess the Relationship Between the Areolar Margin and Underlying Breast Paryenchyma Attachments to the Dermis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Patterns of Breast Gland Attachment
研究概览
简要总结
The purpose of this study is to test a new method of defining patterns of how breast glands are or are not attached to the overlying skin. All patients will have markers placed on both breasts and will undergo an MRI. MRI results will be examined to identify the pattern of breast gland attachment to the overlying skin. This will help identify patients which may benefit from areolar sparing and/or nipple sparing technique and which patients should be treated by standard mastectomy.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have one of the following indications for MRI study of the breast - screening for high risk without evidence of disease, have existing breast cancer with need for evaluation of extent of disease or to rule out additional occult cancer, or to have an equivocal mammogram or ultrasound requiring additional information from MRI.
- •No prior breast surgery including prior excisional biopsies for disease performed with surgical technique, breast augmentation, reduction mammoplasty or breast lift with or without implants.
- •Capable of fitting into the MRI machine.
- •Permission to contact and consent the patient to participate from the investigator(s)
- •Provide written informed consent and Authorization for Use/Disclosure of PHI
排除标准
- •Have a contraindication to MRI study.
- •Prior breast surgery - this includes: prior excisional biopsies for disease performed with surgical technique, breast augmentation, reduction mammoplasty or breast lift with or without implants [Patients may have undergone prior percutaneous (needle) biopsy or fine needle aspiration]
- •Inability to fit into the MRI machine.
- •Psychological factors that may interfere with successful completion of the study
- •Refusal to provide written informed consent and/or Authorization for Use/Disclosure of PHI
结局指标
主要结局
Patterns of Breast Gland Attachment
时间窗: 6 months
Identify the various patterns of breast gland attachment to the overlying skin.
次要结局
未报告次要终点
研究者
研究点 (2)
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