Clinical performance of hemodynamics-based non-invasive device for skin cancer testing

基于血流动力学的非侵入性皮肤癌检测装置的临床表现

• 批准号: 10010649
• 负责人: MIRIANAS CHACHISVILIS
• 金额: $ 116.5万
• 依托单位: VERISKIN, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-15 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10010649
• 关键词: Accounting; Adoption; Affect; Algorithmic Analysis; Assessment tool; Basal Cell; Behavior; Benign; Biopsy; Blood; Blood Vessels; Blood capillaries; Blood flow; Cancer Detection; Cancer Diagnostics; Cancerous; Caregivers; Caring; Certification; Cessation of life; Clinical; Clinical Data; Clinical Research; Clinical Trials; Coupled; Cutaneous; Data Analyses; Decision Making; Dermatologist; Detection; Device Approval; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Early Diagnosis; Effectiveness; Family Practice; Frequencies; Funding; General Practices; General Practitioners; Goals; Hand functions; Health Care Costs; Health Personnel; Healthcare Systems; Image; Institutional Review Boards; Intercellular Fluid; Internal Medicine; Investments; Lead; Lesion; Light; Machine Learning; Malignant - descriptor; Malignant Neoplasms; Malpractice; Measurement; Measures; Methods; Mind; Morphology; Neoplasms; Nevus; Non-Invasive Cancer Detection; Nurse Practitioners; Optics; Painless; Pathologic; Pathologic Neovascularization; Patient-Focused Outcomes; Patients; Performance; Physician Assistants; Physicians; Pigments; Predictive Value; Primary Health Care; Privatization; Probability; Procedures; Process; Provider; Research; Risk; Safety; Savings; Screening for Skin Cancer; Sensitivity and Specificity; Skin; Skin Cancer; Specialist; Specificity; Squamous cell carcinoma; Structure; Technology; Testing; Time; Training; Treatment Cost; Tumor Tissue; Uncertainty; Unnecessary Procedures; Vascular resistance; Work; absorption; accurate diagnosis; base; cancer diagnosis; clinical practice; commercialization; cost; design; hemodynamics; improved; machine learning algorithm; mechanical pressure; melanoma; novel; peace; pressure; response; safety testing; screening; skills; skin lesion; tumor; vascular abnormality

Skin cancer is the most common form of cancer in the US, accounting for just under half of all diagnosed cancers (5+ million diagnoses), 27,000+ deaths each year and the annual treatment costs of over $8.1 billion. The early diagnosis of skin cancer has significant impact on patient outcomes and health care costs but remains highly subjective and requires highly specialized training while existing diagnostic devices offer low positive predictive value which results in both, missed skin cancers as well as a large number of unnecessary biopsies. When a patient presents with a suspicious skin lesion, uncertainty in the initial assessment by a dermatologist may lead to biopsies that suggest that no subsequent treatment is necessary (false positive - FP) while at the same time lesions that are not biopsied may warrant treatment (false negative - FN) potentially giving rise to claims of malpractice. FPs subject patients to unnecessary procedures and the health care system to unnecessary costs. FNs result in delayed treatment, compromising patient outcomes and increasing health care costs. This diagnostic problem is exacerbated when a patient first presents to a primary care practice due to lesser diagnostic performance. Here, some patients may be referred unnecessarily to dermatologists while other cases go undetected. The Veriskin’s TruScore device is a proprietary, non-invasive, low-cost, easy-to-use, hand-held unit that supports the diagnosis of skin cancer. It rapidly and objectively determines whether a suspicious skin lesion is cancerous, reducing the number of FNs and also reducing the need for unnecessary biopsies. The device provides a score of 0% to 100% indicating the probability of malignancy. The TruScore works by detecting and analyzing force-induced hemodynamic abnormalities due to pathological angiogenesis which is a well established early hallmark of cancer. Pilot clinical studies indicate >99% sensitivity and >94% specificity in differentiating of skin cancer from a variety of benign conditions. The device is useful at all levels of care, but the greatest benefits to patients may result when the device is used in primary care practice. The specific goal of this project is to test the device in a larger scale clinical study. The long-term goal of the project is to achieve widespread clinical adoption of this simple-to-use and low-cost non- invasive skin cancer diagnostic method and device that will (1) facilitate sensitive, specific and non-subjective assessment of suspect skin regions by general practice clinicians and nurse practitioners, (2) enable precise targeting of patients for biopsies and/or escalation of care and (3) provide overall reduction in skin cancer treatment costs.

皮肤癌是美国最常见的癌症，占所有诊断的一半以下 癌症（500多万诊断），每年27，000多人死亡，每年治疗费用超过81亿美元。 皮肤癌的早期诊断对患者的预后和医疗保健费用有显著影响， 仍然是高度主观的，需要高度专业化的培训，而现有的诊断设备提供低 阳性预测值，这两个结果，错过了皮肤癌以及大量的不必要的 活组织检查当患者出现可疑皮肤病变时，医生的初步评估存在不确定性 皮肤科医生可能会导致活检，表明没有后续治疗是必要的（假阳性- FP），而同时未活检的病变可能需要治疗（假阴性- FN）， 从而导致医疗事故的指控FP使患者遭受不必要的程序和医疗保健 不必要的成本。FN导致治疗延迟，损害患者结局，并增加 医疗保健费用。当病人第一次出现在初级保健中心时， 由于诊断性能较差，在这里，有些病人可能会被不必要地转诊到 皮肤科医生，而其他案件未被发现。Veriskin的TruScore设备是一种专有的，非侵入性的， 低成本，易于使用，手持设备，支持皮肤癌的诊断。它迅速而客观地 确定可疑的皮肤病变是否是癌性的，减少FN的数量，也减少了 不必要的活检。该器械提供了0%至100%的评分，指示以下概率： 恶性肿瘤TruScore的工作原理是检测和分析力诱导的血流动力学异常， 病理性血管生成是公认的癌症早期标志。初步临床研究表明， >99%的敏感性和>94%的特异性区分皮肤癌从各种良性疾病。的 该器械在所有级别的护理中都是有用的，但当该器械用于 初级保健实践。本项目的具体目标是在更大规模的临床研究中测试该器械。的 该项目的长期目标是实现广泛的临床采用这种简单易用，低成本的非 侵袭性皮肤癌诊断方法和装置，其将（1）促进敏感、特异和非主观 由全科临床医生和执业护士对可疑皮肤区域进行评估，（2）使精确的 针对患者进行活检和/或护理升级，以及（3）提供皮肤癌的总体减少 治疗费用。