SCREENING DEVICE FOR DETECTING SMALL ACOUSTIC TUMORS

用于检测小型声学肿瘤的筛查装置

• 批准号: 2873848
• 负责人: Gabriel Raviv
• 金额: $ 10万
• 依托单位: BIO-LOGIC SYSTEMS CORPORATION
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-09-30 至 2000-03-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2873848
• 关键词: biomedical equipment development; clinical biomedical equipment; clinical research; diagnosis design /evaluation; ear disorder diagnosis; ear neoplasms; electrophysiology; evoked potentials; human subject; neoplasm /cancer diagnosis; sound

Accurate and early detection of small intracanalicular acoustic tumors is difficult with standard Acoustic Brainstem Response (ABR). As a result, expensive enhanced MRI is used to screen patients suspected of having a tumor. Most patients sent for imaging are negative. Development of a compact cost-efficient screening device based on the Stacked Derived-band ABR Amplitude measure is proposed. The aim of this measure is to insure imaging of patients with tumors and substantially reduce imaging of non-tumor patients. Phase I research will demonstrate that clinically acceptable sensitivity and specificity can be achieved and that digital noise masking can be used in this method. In Phase II, we plan to further improve the sensitivity and specificity by optimizing the parameters of the stacked derived- band ABR method. We will test the optimized method on a large clinical population, and validate the method's clinical utility and ease of use in a multi-center study. We will also develop the PC-based prototype (hardware and software) of the screening device. PROPOSED COMMERCIAL APPLICATION The acoustic tumor screening device will be marketed to Otolaryngology and Audiology as a complete diagnostic system as an option on acoustic and multi-modality EP systems. Otolaryngologists and audiologists have the requisite expertise and facilities to administer and evaluate ABR test results, so that this system would require little additional training and no facility development. The screening device will provide significant benefits in terms of improved patient care and reduced diagnostic costs.

标准的听性脑干反应（ABR）很难准确和早期发现小的听神经管内肿瘤。 因此，昂贵的增强MRI被用于筛查疑似患有肿瘤的患者。 大多数被送去做成像的病人都是阴性的。 提出了一种基于叠加导频ABR振幅测量的紧凑型低成本筛选设备的开发。 这项措施的目的是确保肿瘤患者的成像，并大大减少非肿瘤患者的成像。 I期研究将证明，可以实现临床可接受的灵敏度和特异性，并且可以在该方法中使用数字噪声掩蔽。在第二阶段，我们计划通过优化堆叠衍生带ABR方法的参数来进一步提高灵敏度和特异性。 我们将在大量临床人群中测试优化的方法，并在多中心研究中验证该方法的临床实用性和易用性。 我们也将开发基于PC的筛选设备的原型（硬件和软件）。建议的商业应用声学肿瘤筛查设备将作为声学和多模态EP系统的一个选项，作为一个完整的诊断系统销售给耳鼻喉科和听力学。耳鼻喉科医生和听力学家拥有必要的专业知识和设施来管理和评估ABR测试结果，因此该系统几乎不需要额外的培训，也不需要开发设施。 筛查设备将在改善患者护理和降低诊断成本方面提供显著的益处。