Development of an electrical diagnostic for melanoma

描述(申请人提供)：RPN Research最近开发了一种名为生物电场成像仪(BFI)的新仪器，它允许我们在不接触皮肤的情况下测量皮肤的表面电位。我们已经使用BFI绘制了小鼠皮肤伤口周围的横向电场图，并建议在这里确定其在皮肤肿瘤诊断中的有效性。160年来，我们一直知道人类皮肤会将离子流赶出表皮完整性被破坏的区域(DuBois-Reymond，1843)。然后，这一电流在角质层和表皮之间传递，在病变周围产生横向电场。完整、健康的皮肤区域不会表现出这样的横向电场，因此这种电场的存在是伤口或损伤的强烈指示。如果黑色素瘤或基底细胞癌等病变降低了跨越表皮的阻力，我们将有望检测到这些肿瘤附近的横向电场。我们使用了一个小鼠模型系统，在这个系统中，我们通过将B16小鼠黑色素瘤细胞注射到皮肤下来诱导黑色素瘤的发展。我们提出了与这些黑色素瘤相关的横向电场的初步测量。早在我们将黑色素瘤细胞注射到皮肤下的第一天，600 mV/mm或更大的磁场就与这些黑色素瘤有关。要确定这种方法的可靠性，还需要做更多的工作。我们建议进行一项组织学研究，将测量的电场强度与黑色素瘤的大小相关联，并将建立这项技术在皮肤病变诊断中的可靠性。我们还将在人体上进行临床研究，以确定BFI是否可以区分皮肤良性和恶性病变。如果是这样的话，BFI可以通过早期发现皮肤病来改善人类健康，并可能提供一种常规诊断设备，可以减少必要的活检次数。目前，帮助皮肤科医生和其他内科医生诊断皮肤病的医疗设备很少。他们必须依靠过去的经验和对每个患者进行活组织检查的结果(Farmer和Hood，2000)。BFI可以提供有关可疑病变的额外信息，这些信息在做出诊断时可能非常有用。皮肤癌、基底细胞癌、鳞状细胞癌和恶性黑色素瘤这三种最常见的癌症都会导致表皮的破坏，预计会产生BFI可以检测到的局部电场。

DESCRIPTION (provided by applicant): RPN Research has recently developed a new instrument called the Bioelectric Field Imager (BFI) that allows us to measure the surface potential of the skin without touching it. We have used the BFI to map the lateral electric field surrounding a skin wound in mice and propose here to determine its usefulness for the diagnosis of skin tumors. We have known for 160 years that human skin drives ionic current out of regions where the integrity of the epidermis has been breached (DuBois-Reymond, 1843). This current then passes between the stratum corneum and the epidermis, generating a lateral electric field surrounding the lesion. Regions of intact, healthy skin do not exhibit such lateral electric fields so the presence of such fields is a strong indicator of a wound or lesion. If lesions such as melanoma or basal cell carcinoma reduce the resistance across the epidermis, we would expect to detect lateral electric fields near these tumors. We have used a mouse model system in which we induce a melanoma to develop by injecting B16 murine melanoma cells beneath the skin. We present preliminary measurements of lateral electric fields associated with these melanomas. Fields of 600 mV/mm and greater are associated with these melanomas as early as 1 day after we inject the melanoma cells beneath the skin. Much more needs to be done to establish the reliability of this approach. We propose to conduct a histological study to correlate the measured electric field strength with melanoma size and will establish the reliability of this technique for the diagnosis of skin lesions. We will also conduct clinical investigations on humans to determine if the BFI can distinguish between benign and malignant skin lesions. If so, the BFI could improve human health by early detection of skin disease and may provide a routine diagnostic device that could reduce the number of biopsies necessary. There are very few medical devices to aid dermatologists and other physicians in the diagnosis of skin disease at the present time. They must rely on past experience and the results of biopsies performed on each patient (Farmer and Hood, 2000). The BFI can provide additional information about the suspected lesion that may prove very informative in making the diagnosis. The 3 most common forms of skin cancer, basal cell carcinoma, squamous cell carcinoma and malignant melanoma all cause disruptions in the epidermis and would be expected to generate local electric fields that could be detected by the BFI.