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临床试验/NCT01379092
NCT01379092Unknown不适用

An Evaluation of a Self-contained Direct Digital Radiography System for Breast Specimen Imaging

Levine, Gary M. , M.D.2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Breast biopsy specimen will be imaged on standard of care device and on the Trident Specimen Radiography device to compare quality of images.

研究概览

简要总结

The objective of this study is to evaluate the image quality and operation of a self-contained direct digital radiography system for breast specimen imaging.

详细描述

Specimen imaging is an accepted method for evaluating tissue specimens which are obtained either through minimally-invasive breast needle biopsy (MIBB) or breast surgery. Specimen imaging is used to confirm the targeting and sampling adequacy of radiographically apparent breast abnormalities. Specimen images are acquired and then compared to the routine and diagnostic imaging to provide radiographic evidence that the index lesion was adequately targeted and sampled (as in the case of MIBB) or targeted and removed with adequate margins [as in the case of breast surgical specimens (BSS)]. Specimen imaging also provides guidance to the histopathologist when evaluating the breast specimen.

Near real-time image acquisition, review and feedback is essential for specimen imaging. The patient typically remains in compression on the biopsy table for MIBB or under anesthesia for BSS until the clinician has confirmation that the index abnormality has been adequately sampled (in the case of MIBB) or surgically excised. For this reason, digital techniques are favored over analog (film) counterparts because of the immediacy of image acquisition and transfer and display to the radiologist for review.

Image quality and speed are critical factors in specimen imaging. High resolution images are a clinical requirement to delineate the features and extent of mass lesions, and presence and extent of microcalcifications.

Conventional full-field digital (FFDM) mammographic equipment located in the mammography department is one accepted approach for specimen imaging. An advantage of this method is that a licensed and skilled mammographic technologist assures the adequate exposure of specimens. However, this method requires that the FFDM system be free at the time the specimen arrives in the mammography department, interfering with mammogram schedules. In the case of BSS, the use of conventional FFDM systems additionally requires the transport of specimens to the mammography department, adding significant time that the patient is under anesthesia.

Another mode for specimen radiography is self-contained digital radiography specimen imaging systems that are located in the mammography department or in the Operating Room (intraoperative). The use of self-contained digital systems frees the conventional mammography system for its intended purpose, while providing the clinician all the speed of digital radiography.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Breast specimens acquired through MIBB or Surgical techniques arriving for specimen imaging

排除标准

  • Breast specimens that are larger than12 x 14 cm.

结局指标

主要结局

Breast biopsy specimen will be imaged on standard of care device and on the Trident Specimen Radiography device to compare quality of images.

时间窗: 1 Day

Images will be taken at time of biopsy with no additional follow-up time for patient.

次要结局

  • Device Operation(1 Day)

研究者

发起方
Levine, Gary M. , M.D.
申办方类型
Indiv
责任方
Principal Investigator
主要研究者

Gary M Levine, M.D.

Director of Breast Imaging

Levine, Gary M. , M.D.

研究点 (2)

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