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临床试验/NCT00734838
NCT00734838已完成不适用

Optical Spectroscopy During Breast Cancer Surgery and Core Needle Biopsy

Duke University2 个研究点 分布在 1 个国家目标入组 213 人开始时间: 2006年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
213
试验地点
2
主要终点
Optical signatures

研究概览

简要总结

The objective of the proposed research is to develop new diagnostic modalities based on optical spectroscopy (auto fluorescence, absorption, and scattering) for the diagnosis of breast cancer and test its performance as an adjunct to core needle biopsy. For the surgery part of the study, all patients scheduled to have a mastectomy or lumpectomy for the treatment of breast cancer will be asked if they would be willing to participate in this study. For the core needle biopsy part of the study, patients with a higher pre-probability of cancer (based on mammography) will be recruited to increase the number of patients with malignant lesions and enrolled in this investigation.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Device Feasibility
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

入选标准

  • Patients having a needle biopsy of a breast mass

排除标准

  • 未提供

结局指标

主要结局

Optical signatures

时间窗: Day of procedure (less than 10 minutes)

The primary outcome of this study is the identification of the optical signatures of normal and cancerous tissue of the breast

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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