NCT00888589已完成不适用
Improved Sensitivity for the Detection of Aggressive Breast Tumors Using 99mTc-NC100692 and a Dual-headed Small Field of View CZT Gamma Camera.
Michael O'Connor1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evidence of disease confirmed by surgery, or benign disease confirmed by biopsy
研究概览
简要总结
The purpose of this study is to compare two types of radioactive drugs to see if they provide the same or different information about any disease that may be present in the participants breast.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Have a lesion on mammogram, ultrasound or breast MRI that measured < 15 mm in diameter, is considered suggestive or highly suggestive of malignancy according to the Breast Imaging Reporting and Data System Atlas criteria (BIRADS 4b, 4c or 5), and is scheduled for biopsy (needle biopsy and/or surgical biopsy).
- •Have a lesion on mammogram, ultrasound or breast MRI that measured > 15 mm in diameter, is known to be malignant and is scheduled for surgery.
- •Patient age > 18 years of age.
- •Have a negative pregnancy test on the first day of the study, or must be postmenopausal or surgically sterilized.
排除标准
- •Patients will be excluded if they have a small lesion (< 15 mm) and have undergone prior needle biopsy of the lesion (such biopsy may effectively remove all or part of the lesion and angiogenesis associated with wound healing might confound imaging results with 99mTc-NC100692).
- •Patient's pregnancy is not negative on the first day of the study, or the patient is unable to complete the pregnancy test
- •Patient is unable to sit on a chair for 40 minutes
结局指标
主要结局
Evidence of disease confirmed by surgery, or benign disease confirmed by biopsy
时间窗: 30 days
次要结局
未报告次要终点
研究者
Michael O'Connor
Prefessor of Radiologic Physics
Mayo Clinic
研究点 (1)
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