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临床试验/NCT00807404
NCT00807404已完成不适用

Forward Image Guided Ductoscopy for Early Cancer Screening

City of Hope Medical Center2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2006年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Design of a portable forward imaging optical coherence tomography (OCT) needle probe

研究概览

简要总结

RATIONALE: New diagnostic procedures, such as optical coherence tomography, may be effective in finding tumor cells.

PURPOSE: This clinical trial is studying optical coherence tomography in tissue samples from women undergoing mastectomy for the treatment or prevention of breast ductal intraepithelial neoplasia.

详细描述

OBJECTIVES:

  • To design and construct a portable forward imaging optical coherence tomography (OCT) needle probe.
  • To compare OCT imaging of ex-vivo breast tumor tissue sections with histology to form the basis of an image library for in-vivo work.
  • To initiate development of an OCT needle probe that is capable of acquiring core biopsy samples.

OUTLINE: Breast tissue samples are obtained during mastectomy and analyzed ex-vivo by optical coherence tomography (OCT) and by histopathological examination. Once routine pathological evaluation and tissue sampling are completed, OCT imaging is performed using a portable forward imaging needle probe that is inserted through the ducts of the tissue sample. OCT images of the surface of the closest margin to the tumor (if present) as well as images of the duct(s) in the nipple areola complex (after dilation) are obtained. Images of a cross section of the tumor (after the sample has been sliced by the pathologist) are also obtained. The OCT images are then correlated with tissue histology. The images are used to create a correlation histology-OCT atlas for the evaluation of subsequent images and for future reference.

研究设计

研究类型
Interventional
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

入选标准

  • DISEASE CHARACTERISTICS:
  • Undergoing mastectomy at the City of Hope Breast Center for the treatment or prevention of breast ductal intraepithelial neoplasia
  • PATIENT CHARACTERISTICS:
  • Fertile and/or pregnant patients allowed
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics

排除标准

  • 未提供

结局指标

主要结局

Design of a portable forward imaging optical coherence tomography (OCT) needle probe

Comparison of OCT imaging of ex-vivo breast tumor tissue sections with histology

Development of an OCT needle probe that is capable of acquiring core biopsy samples

次要结局

未报告次要终点

研究者

发起方
City of Hope Medical Center
申办方类型
Other

研究点 (2)

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