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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要该提案旨在解决术中评估血液和淋巴管未满足的临床需求脉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。目前的成像系统很笨重，需要关闭房间周围的灯光，成像效果差荧光敏感性，或提供难以解释的图像。 OnLume 将开发临床车- 基于 Asimov 成像平台，可与 FDA 批准的荧光染料吲哚菁结合使用绿色，不仅可以在环境灯打开的情况下实时捕获小型船只的图像，而无需图像对比度下降，但也易于外科医生使用和解释，从而形成一个平台进行优化，以在乳腺癌手术工作流程中的多个程序中提供临床价值。在美国，每年有超过 250,000 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，但这是极其困难的可视化。淋巴水肿是一种与淋巴管损伤相关的不治之症，可能发生在 40% 的乳腺癌幸存者；相关症状包括疼痛、沉重和活动受限相关费用每年从 3000 美元到 16,000 美元不等。切除从淋巴结引流的淋巴结乳房同时保留淋巴管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游离皮瓣手术进行乳房重建，其中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冢。外科医生必须评估血管通畅性，以降低组织坏死和继发性病变的风险运营。在 15-25% 的病例中，患者需要接受二次手术来纠正组织坏死，从而产生费用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试点研究中进行评估，以衡量可视化效果血液和淋巴结构。第二阶段提案有三个具体目标：（1）完成开发并将新技术集成到临床瞬态照明、宽视场荧光引导基于手术车的成像平台，(2) 证明腋窝反转的淋巴管对比度增强标测（ARM），（3）评估游离皮瓣乳房重建中的血管通畅性。成功的完成后将产生商业化的临床广域 FGS 成像系统，提供关键的术中成像可以使乳腺外科医生和整形外科医生改善健康状况乳腺癌幸存者的生活质量。

项目成果

期刊论文数量（6）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

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
影响因子：
0
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
影响因子：
0
作者：
Karim AS;Liu A;Lin C;Uselmann AJ;Eliceiri KW;Brown ME;Gibson ALF
通讯作者：
Gibson ALF

Development of a drug-device combination for fluorescence-guided surgery in neuroendocrine tumors.

DOI：
10.1117/1.jbo.25.12.126002
发表时间：
2020-12
期刊：
Journal of biomedical optics
影响因子：
3.5
作者：
Hernandez Vargas S;Lin C;Voss J;Ghosh SC;Halperin DM;AghaAmiri S;Cao HST;Ikoma N;Uselmann AJ;Azhdarinia A
通讯作者：
Azhdarinia A