Ergonomic fluorescence-guided surgery imaging platform for intraoperative assessment of blood and lymphatic vasculature

符合人体工程学的荧光引导手术成像平台，用于术中评估血液和淋巴管系统

• 批准号: 10249334
• 负责人: Adam John Uselmann
• 金额: $ 82.25万
• 依托单位: ONLUME, LLC
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-21 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10249334
• 关键词: Abdomen; Address; Anastomosis - action; Animals; Architecture; Axilla; Axillary Lymph Node Dissection; Axillary lymph node group; Blood; Blood Vessels; Breast; Breast Cancer Patient; Breast Cancer Treatment; Breast Cancer survivor; Breast Oncology; Caliber; Clinical; Computer software; Cues; Detection; Development; Diagnosis; Disease; Dyes; Excision; Extravasation; FDA approved; Failure; Fluorescence; Fluorescent Dyes; Health; Image; Image-Guided Surgery; Imaging Device; Imaging Phantoms; In Vitro; Indocyanine Green; Injections; Institution; Institutional Review Boards; Interruption; Isosulfan Blue; Light; Lighting; Lymph Node Mapping; Lymphatic; Lymphedema; Mammaplasty; Maps; Mastectomy; Measurable; Measures; Methods; Morbidity - disease rate; Noise; Operative Surgical Procedures; Pain; Palpation; Patients; Performance; Perfusion; Phase; Pilot Projects; Plastic Surgeon; Postoperative Period; Prevalence; Procedures; Quality of life; Research; Resolution; Risk; Sentinel Lymph Node Biopsy; Signal Transduction; Site; Surgeon; Surgical Flaps; Surgical Oncologist; System; Techniques; Time; Tissues; Translating; United States; Visual; Visualization; Woman; Work; arm; associated symptom; base; breast surgery; cancer surgery; cell motility; clinical imaging; commercialization; contrast enhanced; contrast imaging; cost; design; detection sensitivity; draining lymph node; experience; fluorescence-guided surgery; imaging platform; imaging system; improved; in vivo; lymphatic drainage; lymphatic vasculature; lymphatic vessel; malignant breast neoplasm; necrotic tissue; new technology; novel; operation; preservation; real-time images; reconstruction; repaired; standard of care; user friendly software

Project Summary/Abstract This proposal aims to address the unmet clinical need for intraoperative assessment of blood and lymphatic vasculature to reduce the prevalence of two breast cancer-related morbidities: lymphedema and tissue necrosis. Current imaging systems are cumbersome, requiring ambient room lights to be turned off, have poor fluorescence sensitivity, or provide images that are difficult to interpret. OnLume will develop the clinical cart- based Asimov Imaging Platform to work in combination with the FDA-approved fluorescent dye, indocyanine green, that not only enables real-time image capture of small vessels with ambient lights on without degradation to image contrast, but also is easy for surgeons to use and interpret resulting in a platform that will be optimized to provide clinical value across multiple procedures in the breast cancer surgery workflow. More than 250,000 women a year undergo surgery for breast cancer in the United States. Conventionally, surgeons rely on white light reflectance as a guide to assessing vessel patency, which is extremely difficult to visualize. Lymphedema, an incurable disease associated with damage to lymphatic vessels, may occur in up to 40% of breast cancer survivors; associated symptoms include pain, heaviness and limitations in motility and associated costs range from $3000 to $16,000 per annum. Resection of lymph nodes that drain from the breast while sparing the lymphatic channels may decrease the risk of lymphedema. Some women who undergo mastectomy may choose breast reconstruction with a free flap surgery, where plastic surgeons reattach blood vessels between donor and recipient tissue sites to reconstruct a breast mound. Surgeons must assess vessel patency to decrease the risk of tissue necrosis and secondary operations. In 15-25% of cases, patients undergo secondary surgery to correct tissue necrosis, incurring costs that can exceed $14,000 per procedure. Our novel imaging system will be evaluated in a pilot study to measure the efficacy of the visualization of the blood and lymphatic architecture. This Phase II proposal has three specific aims: (1) complete development and integration of novel technology into a clinical transient lighting-enabled, wide-field fluorescence-guided surgery cart-based imaging platform, (2) demonstrate enhanced contrast of lymphatics for axillary reverse mapping (ARM), and (3) evaluate blood vessel patency in free flap breast reconstruction. Successful completion will result in a commercially available clinical wide-field FGS imaging system, providing critical intraoperative imaging that could enable breast surgeons and plastic surgeons to improve the health and quality of life for breast cancer survivors.

项目摘要/摘要 本提案旨在解决未得到满足的术中血液和淋巴管评估的临床需求。 血管系统可降低两种乳腺癌相关疾病的患病率：淋巴水肿和组织 坏死。目前的成像系统繁琐，需要关闭房间的灯，具有较差的性能 荧光敏感度，或提供难以解释的图像。OnLume将开发临床手推车- 基于Asimov成像平台与FDA批准的荧光染料吲哚青氨酸结合使用 绿色，这不仅可以在没有环境光的情况下实时捕获小船的图像 降级到图像对比度，但也易于外科医生使用和解释，从而产生一个将 经过优化，在乳腺癌手术工作流程中提供跨多个程序的临床价值。 在美国，每年有超过25万名女性接受乳腺癌手术。按照惯例， 外科医生依靠白光反射率作为评估血管通畅性的指南，这是极其困难的 想象一下。淋巴水肿是一种与淋巴管受损有关的不治之症，可发生在UP中。 至40%的乳腺癌幸存者；相关症状包括疼痛、沉重和活动受限，以及 相关费用每年从3000美元到16000美元不等。淋巴引流的淋巴切除术 乳房同时保留淋巴通道可能会降低淋巴水肿的风险。 一些接受乳房切除术的女性可能会选择用游离乳房瓣手术进行乳房再造， 整形外科医生在供体和受体组织部位之间重新连接血管以重建乳房 投手丘。外科医生必须评估血管的通畅性，以降低组织坏死和继发性疾病的风险 行动。在15%-25%的病例中，患者接受二次手术以纠正组织坏死，这会产生成本 每次手术的费用可能超过14,000美元。 我们的新型成像系统将在一项初步研究中进行评估，以衡量 血液和淋巴结构。这项第二阶段的建议有三个具体目标：(1)全面发展 并将新技术集成到临床瞬变照明、广域荧光引导中 基于手术车的成像平台，(2)显示腋窝反向淋巴管的增强对比 (3)评价游离瓣乳房重建术中血管通畅性。成功 建成后将产生一种可商业化的临床广域FGS成像系统，提供关键的 术中成像可以使乳房外科医生和整形外科医生改善健康和 乳腺癌幸存者的生活质量。

项目成果

Receptor-Targeted Fluorescence-Guided Surgery With Low Molecular Weight Agents.

• DOI: 10.3389/fonc.2021.674083
• 发表时间: 2021
• 期刊: Frontiers in oncology
• 影响因子: 4.7
• 作者: Hernandez Vargas S;Lin C;Tran Cao HS;Ikoma N;AghaAmiri S;Ghosh SC;Uselmann AJ;Azhdarinia A
• 通讯作者: Azhdarinia A

Lighting the Way for Necrosis Excision Through Indocyanine Green Fluorescence-Guided Surgery.

通过吲哚菁绿荧光引导手术照亮坏死切除之路。

• DOI: 10.1097/xcs.0000000000000329
• 发表时间: 2022
• 期刊: Journal of the American College of Surgeons
• 影响因子: 5.2
• 作者: Zajac,JocelynC;Liu,Aiping;Uselmann,AdamJ;Lin,Christie;Hassan,SameehaE;Faucher,LeeD;Gibson,AngelaLf
• 通讯作者: Gibson,AngelaLf

A proof-of-concept methodology to validate the in situ visualization of residual disease using cancer-targeted molecular agents in fluorescence-guided surgery.

一种概念验证方法，用于验证在荧光引导手术中使用癌症靶向分子制剂对残留病灶进行原位可视化。

• DOI: 10.1117/12.2546190
• 发表时间: 2020
• 期刊: Proceedings of SPIE--the International Society for Optical Engineering
• 作者: Vargas,ServandoHernandez;Lin,Christie;AghaAmiri,Solmaz;Voss,Julie;Ikoma,Naruhiko;TranCao,HopS;Ghosh,SukhenC;Uselmann,AdamJ;Azhdarinia,Ali
• 通讯作者: Azhdarinia,Ali

Evolution of ischemia and neovascularization in a murine model of full thickness human wound healing.

• DOI: 10.1111/wrr.12847
• 发表时间: 2020-11
• 期刊: Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society
• 作者: Karim AS;Liu A;Lin C;Uselmann AJ;Eliceiri KW;Brown ME;Gibson ALF
• 通讯作者: Gibson ALF

Augmentation of Chicken Thigh Model with Fluorescence Imaging Allows for Real-Time, High Fidelity Assessment in Supermicrosurgery Training.

使用荧光成像的鸡大腿模型的增强可以在超级外科手术训练中进行实时高保真评估。

• DOI: 10.1055/s-0040-1722184
• 发表时间: 2021-07
• 期刊: JOURNAL OF RECONSTRUCTIVE MICROSURGERY
• 影响因子: 2.1
• 作者: Albano, Nicholas J.;Zeng, Weifeng;Lin, Christie;Uselmann, Adam J.;Eliceiri, Kevin W.;Poore, Samuel O.
• 通讯作者: Poore, Samuel O.