NCT00040430Unknown1 期
Study of 111In-DAC as a Medical Imaging Agent for the Detection of Breast Cancer
Copharos2 个研究点 分布在 1 个国家开始时间: 2002年6月28日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 试验地点
- 2
研究概览
简要总结
The purpose of this study is to investigate the safety and imaging ability of 111In-DAC when used with planar and SPECT imaging for the detection of breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients will be eligible for the study if they:
- •Are non-pregnant, non-lactating females 18 years of age or older(must agree to use an appropriate and effective method of birth control during the study and for 2 weeks after study)
- •Are being evaluated for a known or suspected breast tumor (must present with either a mammographic abnormality 10mm or larger or a mammographically occult but palpable abnormality of the breast)
- •Have been previously scheduled for biopsy or surgical excision of the known or suspected tumor of the breast
- •Have signed an informed consent form
排除标准
- •Patients will not be eligible for this study if they:
- •Have a history or suspicion of significant allergic reaction or anaphylaxis to any of the 111In-DAC components
- •Have a clinically unstable medical condition or opportunistic infection, a life-threatening disease state, impaired renal or hepatic function or are immunosuppressed
- •Are taking or have taken part in any investigational study within 30 days of start of study
- •Have received an indium agent within 30 days of start of study
- •Are not able to remain immobile during scanning time
- •Have taken drugs that may damage the kidneys within 2 weeks of start of study
- •Have abnormal laboratory test results: hemoglobin < 9.5 gms/dl, serum creatinine > 1.5 mg/100ml, alkaline phosphatase 2X the upper limit of normal
- •Have undergone an excisional and/or needle localization biopsy within 4 days prior to start of study
研究者
研究点 (2)
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