Endoscopic Detection of Fluorescein for Sentinel Lymph Node Biopsy

前哨淋巴结活检中荧光素的内镜检测

• 批准号: 7253246
• 负责人: JAMES M MCGREEVY
• 金额: $ 15.43万
• 依托单位: VESTAN, INC.
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-07-01 至 2009-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7253246
• 关键词: Address; Adult; Anaphylaxis; Axillary Lymph Node Dissection; Biopsy; Cancer Patient; Dermis; Detection; Devices; Drug usage; Dyes; Effectiveness; Endoscopes; Endoscopy; Facility Construction Funding Category; Family suidae; Fluorescein; Fluoresceins; Fluorescence; Gamma Rays; Grant; Human; Image; Intestines; Invasive; Light; Lighting; Limb structure; Lymph Node Dissections; Lymphatic; Lymphatic vessel; Lymphazurin; Maps; Methods; Modeling; Operating Rooms; Operative Surgical Procedures; Optics; Patients; Pharmaceutical Preparations; Phase; Positioning Attribute; Radioactive; Radiopharmaceuticals; Risk; Sentinel Lymph Node; Sentinel Lymph Node Biopsy; Small Business Funding Mechanisms; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Source; Surgeon; Surgical Management; Surgical incisions; Sus scrofa; Technetium Tc 99m Sulfur Colloid; Techniques; Testing; Time; Tissues; United States Food and Drug Administration; Woman; breast lumpectomy; cancer type; cost; detector; instrument; instrumentation; lymph nodes; malignant breast neoplasm; notch protein; novel strategies; prototype; success

DESCRIPTION (provided by applicant): The objective of this grant is to develop fluorescence endoscopy instrumentation to facilitate the surgical management of breast cancer, with possible application to other types of cancer. The specific aims for this project are to develop a combination holographic notch filter adapter and switchable high-intensity LED light source adapter for currently available surgical telescopes. This new device will allow the surgeon to perform the axillary dissection of lymph nodes in breast cancer patients with minimally-invasive surgical techniques. This new device will be a more efficient, more accurate, more cost-effective and safer way to perform the sentinel lymph node dissection of lymph node clusters in breast cancer patients. Illumination of a fluorescent lymphatic mapping agent with an appropriately matched fluorescent light source will be more efficient as red- shifted red and near-infrared fluorescent light is visible through many layers of tissue. This may reduce operating room time and obviate the need for a complete axillary dissection which is needed with the currently used visible dye marker (Lymphazurin(r). This device will be more accurate than the gamma ray detector used to find the radioactive marker (technetium sulfur colloid). Fluorescence endoscopy will be less-expensive per patient, as it replaces two imaging agent drugs (one of which is radioactive). Vestan will produce several prototype holographic optical notch filters and switchable high-intensity LED light sources that are matched to the FDA- approved fluorescent drug, fluorescein. The optical notch filter will attach directly to currently used surgical telescopes for the convenience of the operators. Fluorescein is available to all surgeons and it is currently used to determine intraoperative bowel viability. Vestan will demonstrate the feasibility of the device in a pig model of lymphatic mapping. Fluorescein will be injected into the dermis of the hind limb of adult pigs. The fluorescence endoscopy instrumentation will be used to define the lymphatic vessels and to find the sentinel lymph node with minimally-invasive surgical techniques. The accuracy of the device will be evaluated against the currently used blue dye, Lymphazurin(r). Since 200,000 new cases of breast cancer occur each year, and all require an axillary lymph node dissection, this new approach will benefit thousands of women, using three % inch incisions to replace an 8 inch incision. In addition, this new method of finding the sentinel lymph node with fluorescence avoids the use of radioactive drugs and the use of a dye that is associated with a 1% risk of anaphylactic shock.

描述（由申请人提供）：该资助的目的是开发荧光内窥镜仪器，以促进乳腺癌的手术治疗，并可能应用于其他类型的癌症。该项目的具体目标是为目前可用的手术望远镜开发组合全息陷波滤波器适配器和可切换高强度LED光源适配器。这种新设备将允许外科医生使用微创手术技术对乳腺癌患者进行腋窝淋巴结清扫。这种新设备将是一种更有效、更准确、更经济和更安全的方法，用于乳腺癌患者淋巴结簇的前哨淋巴结清扫。用适当匹配的荧光光源照射荧光淋巴映射剂将更有效，因为红移的红色和近红外荧光通过许多组织层可见。这可以减少手术室时间，并减少目前使用的可见染料标记物（Lymphazurin（r））所需的完全腋窝清扫的需要。该装置将比用于寻找放射性标记物（锝硫胶体）的伽马射线探测器更准确。荧光内窥镜检查将降低每位患者的费用，因为它取代了两种成像剂药物（其中一种是放射性的）。Vestan将生产几种原型全息光学陷波滤波器和可切换的高强度LED光源，这些光源与FDA批准的荧光药物荧光素相匹配。光学陷波滤波器将直接连接到目前使用的手术望远镜，以方便操作者。所有外科医生都可以使用黄绿素，目前用于确定术中肠道活力。Vestan将在猪淋巴标测模型中证明该器械的可行性。将黄绿素注射到成年猪后肢的真皮中。荧光内窥镜仪器将用于确定淋巴管，并通过微创手术技术找到前哨淋巴结。将根据当前使用的蓝色染料Lymphazurin（r）评价器械的准确度。由于每年有200，000例乳腺癌新发病例，并且都需要腋窝淋巴结清扫，这种新方法将使数千名妇女受益，使用3%英寸的切口取代8英寸的切口。此外，这种用荧光寻找前哨淋巴结的新方法避免了使用放射性药物和使用与1%过敏性休克风险相关的染料。