Development of an electrical diagnostic for melanoma

描述（由申请人提供）：RPN Research最近开发了一种名为生物电场成像仪（BFI）的新仪器，该仪器允许我们在不接触皮肤的情况下测量皮肤的表面电位。我们使用BFI绘制了小鼠皮肤伤口周围的横向电场，并在此提出确定其对皮肤肿瘤诊断的有用性。160年前我们就知道，人类皮肤会将离子电流从表皮完整性受损的区域排出（DuBois-Reymond，1843）。然后，该电流在角质层和表皮之间通过，在损伤周围产生横向电场。完整的健康皮肤区域不表现出这种横向电场，因此这种场的存在是伤口或病变的强烈指示。如果像黑色素瘤或基底细胞癌这样的病变降低了穿过表皮的电阻，我们将期望在这些肿瘤附近检测到横向电场。我们已经使用了小鼠模型系统，其中我们通过在皮肤下注射B16鼠黑色素瘤细胞来诱导黑色素瘤发展。我们目前的初步测量与这些黑色素瘤的横向电场。早在我们将黑素瘤细胞注射到皮肤下后1天，600 mV/mm及以上的电场就与这些黑素瘤相关。要确定这种方法的可靠性，还有许多工作要做。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，并将建立这种技术用于皮肤病变诊断的可靠性。我们还将对人类进行临床研究，以确定BFI是否可以区分良性和恶性皮肤病变。如果是这样的话，BFI可以通过早期检测皮肤病来改善人类健康，并可以提供一种常规诊断设备，可以减少必要的活检次数。目前很少有医疗设备来帮助皮肤科医生和其他医生诊断皮肤病。他们必须依靠过去的经验和对每个病人进行活检的结果（Farmer和Hood，2000）。BFI可以提供关于可疑病变的额外信息，这些信息在诊断中可能非常有用。3种最常见的皮肤癌形式，基底细胞癌，鳞状细胞癌和恶性黑色素瘤都引起表皮破坏，预计会产生可被BFI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.