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临床试验/NCT00625417
NCT00625417已完成不适用

Breast Tumor Detection Using Optical Spectroscopy

Vanderbilt University3 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2006年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
102
试验地点
3
主要终点
Development of a non-invasive detection tool that evaluates breast tumor margins in real-time to guide tumor resection during partial mastectomy procedures

研究概览

简要总结

RATIONALE: Diagnostic procedures, such as optical spectroscopy, may help learn the extent of disease and allow doctors to plan better treatment.

PURPOSE: This phase I trial is studying optical spectroscopy to see how well it works in evaluating tumor margins in patients who have undergone surgery for breast cancer.

详细描述

OBJECTIVES:

  • To develop a non-invasive detection tool that evaluates breast tumor margins in real-time to guide tumor resection during partial mastectomy procedures.
  • To conduct an ex vivo optical spectroscopic study in operating rooms on breast tissue samples obtained immediately following resection to assess the efficacy of using this tool in differentiating breast tumor or tumor margins from normal breast tissue.

OUTLINE: Breast tissue samples obtained immediately following resection are examined in the operating room using optical spectroscopy to evaluate the margin tissue. During spectroscopy, all lights, except for the surgical lights, are turned off and the lateral, superior, medial, inferior, deep, and anterior margins of the breast tissue sample are examined using a fiber-optic probe, a nitrogen laser, and a broad band white light source. Reflectance and fluorescence spectra are measured at each of these margins by a system operator. The measured margins are then immediately marked by sutures placed by the surgeon. Additional margins may be measured at the surgeon's and system operator's discretion. The breast tissue sample is then delivered to surgical pathology, where shave biopsies are performed at the suture-marked sites to provide a direct correlation between spectroscopy measurements and tissue pathology.

Data collected in this study, including spectral data, gross diagnosis of the patient's tumor, and histological identities of all specimens collected, will be kept in the research record for at least 6 years after the study is finished.

研究设计

研究类型
Interventional
分配方式
Na
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 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •DISEASE CHARACTERISTICS:
  • •Scheduled to undergo lumpectomy, partial or radical mastectomy, or excisional biopsy for breast tumor at Vanderbilt University Hospital
  • •Hormone receptor status not specified
  • •PATIENT CHARACTERISTICS:
  • •Male or female
  • •Menopausal status not specified
  • •Not pregnant
  • •PRIOR CONCURRENT THERAPY:
  • •See Disease Characteristics
  • •INCLUSION CRITERIA Only adult patients between the ages of 18-99 years with breast tumor undergoing lumpectomy, radical mastectomy or excisional biopsy procedure will be considered

排除标准

  • •Pregnant women will be excluded from the participation.

研究组 & 干预措施

Optical spectroscopy on tumor margins

Experimental

Optical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery

干预措施: light-scattering spectroscopy (Procedure)

Optical spectroscopy on tumor margins

Experimental

Optical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery

干预措施: therapeutic conventional surgery (Procedure)

Optical spectroscopy on tumor margins

Experimental

Optical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery

干预措施: breast biopsy (Procedure)

Optical spectroscopy on tumor margins

Experimental

Optical spectroscopy is performed on breast tumor margins obtained from patients undergoing surgery

干预措施: histopathologic examination (Procedure)

结局指标

主要结局

Development of a non-invasive detection tool that evaluates breast tumor margins in real-time to guide tumor resection during partial mastectomy procedures

时间窗: 1 year

A 3-D scanner that can scan a breast lump will be developed so that breast margin may be evaluated with Raman spectroscopy

Evaluated optical spectroscopy in differentiating breast tumor or tumor margins from normal breast tissue

时间窗: 2 years

This device will be tested in patient specimens intra-operatively before going to pathology and compared to histopathology to evaluate the ability of the device to detect margin up to 2 mm deep

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anita Mahadevan-Jansen

Professor, Biomedical Engineering

Vanderbilt University

研究点 (3)

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