DEVELOPMENT OF AN ELECTRICAL DIAGNOSTIC FOR MELANOMA

描述（由申请人提供）：RPN Research开发了一种新的医疗器械，生物电场成像仪（BFI），可以无创地测量人体皮肤中的电场。手持式BFI在不与皮肤接触的情况下扫描皮肤上的振动传感器，并在约1分钟内绘制1 cm距离上的表面电位分布。在该项目的第一阶段使用这种新型成像仪的台式版本，我们首次揭示了小鼠恶性黑色素瘤产生的电场可以很容易地被BFI检测到。这些研究发现，早在注射黑色素瘤细胞后一天就可以检测到电场，并且电场强度与黑色素瘤的大小和生长速度成正比。我们还完成了一项I期临床试验，使用手持式BFI测量良性和恶性人类皮肤病变中的电场，并发现恶性基底细胞癌和鳞状细胞癌也会在人类皮肤中产生大电场。在我们的临床试验中，我们发现手持式BFI在研究中的四个恶性病变中的三个（3个基底细胞癌和1个鳞状细胞癌）的边界处检测到平均696 mV/mm的电场。在我们的第一次人体临床试验中，75%的可靠性令人鼓舞。此外，在良性病变附近测得的平均电场（223 mV/mm）仅为恶性病变附近的三分之一，因此很容易区分两者。在13个良性病变中的9个（70%）中，我们检测到非常小的电场，并在盲法研究中正确预测它们不是恶性的。在本阶段II SBIR期间，我们将改进手持式BFI的设计，使其更轻便、无线且与更广泛的病变形状兼容，从而使其更加通用和可靠。我们将完成至少300名患者的II期临床试验，以确定这种新仪器在快速区分恶性和良性皮肤病变方面的可靠性。我们还将比较用BFI测量的黑色素瘤附近的电场与使用传统微电极测量的电场，以确认BFI的准确性，并进一步证明其优于直接接触测量方法。如果手持式BFI能够可靠地检测恶性皮肤病变，仅在美国就将改善数万名皮肤病患者的生活质量。

DESCRIPTION (provided by applicant): RPN Research has developed a new medical device, the Bioelectric Field Imager (BFI) which can measure the electric field in human skin non-invasively. The hand-held BFI scans a vibrating sensor over the skin without making contact with it and plots the surface potential distribution over a 1 cm distance in about 1 minute. Using a table-mounted version of this new imager in Phase I of this project, we have revealed for the first time that malignant melanomas in mice generate an electric field that can be easily detected by the BFI. These studies found that the electric field can be detected as early as one day after injection of the melanoma cells and the electric field strength is proportional to both the size and growth rate of the melanoma. We have also completed a Phase I Clinical Trial using the hand-held BFI to measure the electric field in both benign and malignant human skin lesions and have found that malignant basal and squamous cell carcinomas generate large electric fields in human skin as well. In our Clinical Trial we found that the hand-held BFI detected an electric field averaging 696 mV/mm at the borders of three of the four malignant lesions in the study (3 basal cell carcinomas and 1 squamous cell carcinoma). This 75% reliability rate in our first human clinical trial is encouraging. In addition, the average electric field measured near benign lesions (223 mV/mm) was only one-third the size of those near malignant lesions, making it very easy to distinguish between the two. In 9 out of 13 benign lesions (70%) we detected a very small electric field and correctly predicted in a blinded study they were not malignant. During this Phase II SBIR we will refine the design of the hand-held BFI to make it more versatile and reliable for human use my making it lighter, wireless and compatible with a wider variety of lesion shapes. We will complete a Phase II Clinical Trial with at least 300 patients to establish the reliability of this new instrument for rapidly distinguishing malignant from benign skin lesions. We will also compare the electric field near melanomas as measured with the BFI to that measured using conventional microelectrodes to both serve as a confirmation of the accuracy of the BFI and to further demonstrate its advantages over the direct contact measurement approach. If the handheld BFI is able to reliably detect malignant skin lesions, it will improve the quality of life for tens of thousands of dermatology patients in the United States alone.