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Emory与SpectRx开展新型宫颈癌检测设备的临床试验

【 2005-02-28 发布 】 美迪医讯
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针对一项新型无创性宫颈癌检测设备的临床试验获得了美国Emory大学(Atlanta, GA, USA)Gerogia研究联盟及其合作伙伴SpectRx公司(Norcross, GA, USA)的资金支持,该公司是这种设备的开发者。

这项拨款将被用于Grady Memorial医院(Atlanta, GA, USA)的该技术的临床试验,将由Emory大学的Lisa Flowers医生负责。这种无创宫颈癌检测设备使用技术没有痛苦无需侵入鉴别癌症和癌前病变,通过分析宫颈的光放射来完成。这种设备建立宫颈图像,突出显示病变位置和严重程度。这项技术通过在细胞水平检测生化与形态学改变来区分正常和病变组织。与Pap检测不同,该技术需要组织样本或者实验室分析,而且可以快速得到检查结果。

一项临床前的关键研究,由美国国立癌症研究员资助,提示这种检测把Pap假阳性检测结果所导致的非必要的随访手术降低了55%,为节约了医疗保健系统的巨大支出。宫颈癌是最常见的位列第三位的女性癌症。

Flowers医生说:“这种新技术为解决目前存在的宫颈癌早期检测的障碍提供了可能。它免除了患者在检测之后数日内焦急等待检查结果,消除了许多假阳性检测结果,这种假阳性无论对患者还是医疗保健系统都是一个沉重的负担。”
 
Trials for Cervical-Cancer Detection Device
 
Clinical trials for a new noninvasive cervical-cancer detection device are being supported by a grant to Emory University (Atlanta, GA, USA) from the Georgia Research Alliance (GRA) in partnership with SpectRx, Inc. (Norcross, GA, USA), the developer of the device.

The grant will be used for the clinical trial of the technology at Grady Memorial Hospital (Atlanta, GA, USA) under the guidance of Dr. Lisa Flowers of Emory University. The noninvasive cervical-cancer detection device uses proprietary technology to identify cancers and precancers painlessly and noninvasively by analyzing light reflected from the cervix. The device creates an image of the cervix that highlights the location and severity of disease. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphologic changes at the cellular level. Unlike Pap tests, this test does require a tissue sample or laboratory analysis, and results are instantly available.

A pre-pivotal clinical study, sponsored by the U.S. National Cancer Institute, indicated that the test could reduce by 55% the number of unnecessary follow-up procedures as a result of false-positive Pap results, with huge cost savings to the healthcare system. Cervical cancer is the third most common cancer among women.

“This new technology offers the potential to overcome many of the barriers to early detection of cervical cancer that exist today,” said Dr. Flowers. “It could eliminate the anxiety of waiting for days for test results and many of the false-positive results that are a burden on the patient and the healthcare system.”

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