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临床试验/NCT00734955
NCT00734955已完成不适用

An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients

Duke University2 个研究点 分布在 1 个国家目标入组 485 人开始时间: 2006年5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
485
试验地点
2
主要终点
Identification of the optical signatures of breast tissue.

研究概览

简要总结

Our objective is to develop a novel optical assay system for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. Our group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. We have also shown that data collection and processing from a single point on the tissue specimen requires less than 5 seconds. In addition, the technique is easily adaptable to provide sensing depths that are required for breast margin assessment. The goal of the work proposed in this protocol is to test the sensitivity and specificity of an optical assay system developed by our group, for intra operative assessment of breast tumor margins.

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
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of Breast Cancer

排除标准

  • 未提供

结局指标

主要结局

Identification of the optical signatures of breast tissue.

时间窗: Day of procedure

The primary outcome measure of this study is to identify the optical signatures of normal and cancerous tissue.

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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