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Intra-operative confocal imaging to guide Mohs surgery

术中共聚焦成像指导莫氏手术

基本信息

批准号：
8323371
负责人：
MILIND RAJADHYAKSHA
金额：
$ 80.46万
依托单位：
SLOAN-KETTERING INST CAN RESEARCH
依托单位国家：
美国
项目类别：
财政年份：
2010
资助国家：
美国
起止时间：
2010-09-30 至 2015-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8323371
关键词：
Aluminum Anesthesia procedures Area Atlas of Cancer Mortality in the United States Basal cell carcinoma Biopsy Bladder Breast Cellular Morphology Cervical Chloride Ion Chlorides Clinical Clinical Research Confocal Microscopy Contrast Media Dermatology Detection Development Diagnosis Epidermis Excision Face Freezing Funding Funding Opportunities Future Goals Gold Head and neck structure Healthcare Human Image In Situ Incidence Laboratories Lateral Left Liver Malignant Neoplasms Maps Microscope Mohs Surgery Morphology Motivation National Institute of Biomedical Imaging and Bioengineering Normal tissue morphology Nuclear Operating Rooms Operative Surgical Procedures Optics Oral Pain Pathology Patients Preparation Procedures Resolution Scanning Screening procedure Sensitivity and Specificity Shave Biopsy Skin Skin Cancer Squamous cell carcinoma Staining method Stains Surgical wound Technology Testing Time Tissues Topical application Translating base cancer type cost image guided intervention in vivo instrument instrumentation interest intervention program melanoma public health relevance response

项目摘要

DESCRIPTION (provided by applicant): The goal of this project is to translate a bench-top line-scanning confocal microscope into a clinical instrument for intra-operative imaging during Mohs surgery, and to test feasibility for detecting basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) margins on patients, using aluminum chloride as a contrast agent for staining nuclear morphology in reflectance. Reaching clinically expected sensitivity and specificity will be the quantitative milestones to validate and demonstrate a technology platform for Mohs surgery in skin and other potentially diverse intra-operative imaging applications. The motivation is to create a relatively simple, small and low-cost confocal microscope for real-time imaging in reflectance, to guide surgery in diverse settings. The proposed immediate application is intra-operative mapping of BCCs and SCCs to guide Mohs surgery. Future applications may include mapping of cancers to guide surgery in oral, head-and-neck, breast, bladder, liver and other tissues. BCCs and SCCs occur with among the highest rates of incidence, with an estimated 1.3 million new cases diagnosed and an estimated 1 million surgeries performed every year in the USA alone. Surgery is guided by frozen pathology which is labor-intensive and time-consuming. Confocal microscopy images nuclear detail in vivo and thus may enable intra-operative mapping directly on the patient in real-time. Rapid examination of cancer margins may be performed on surgically exposed tissue in situ, to guide accurate and complete excision, while preserving surrounding normal tissue. The imaging may serve as an adjunct to pathology for guiding surgery, while saving labor and cost. Patients may benefit with more efficient procedures, less anesthesia and less time in the operating room. Preliminary results demonstrate the feasibility of detecting BCCs, with topically applied aluminum chloride to enhance cancer-to-normal tissue contrast, in surgically-exposed shave-biopsy wounds in situ on patients. Furthermore, a laboratory bench-top line-scanning confocal microscope demonstrates excellent imaging of nuclear and cellular detail in human skin in vivo. The optical sectioning is 1.7 ¿m and lateral resolution is 0.8 ¿m, which is comparable to that of pathology. The hardware cost of the bench-top microscope is less than $15,000. Our hypothesis is that the bench-top line-scanning instrumentation may be translated toward a compact confocal microscope for use at-the-bedside. Rapid and safe staining of nuclear morphology with aluminum chloride may enable intra-operative mapping, in reflectance contrast, of BCCs and SCCs to guide surgery. The specific aims are (1) to build a compact line-scanning confocal microscope for intra-operative imaging in reflectance contrast, and (b) to test the microscope and aluminum chloride-based contrast for intra operative detection of BCC and SCC margins in surgical wounds in situ during Mohs surgery, in a pilot clinical study on 60 patients. Sensitivity and specificity will be determined, against the gold standard of Mohs frozen pathology, to validate the feasibility of the technology. PUBLIC HEALTH RELEVANCE: Confocal microscopy may enable screening and diagnosis of skin cancers such as melanomas and basal- and squamous-cell carcinomas, or may guide surgery of such cancers, directly and in real-time on the patient. The screening, diagnosis or surgical guidance may be noninvasive, with minimal need for biopsy, minimal pain and minimal expense. In dermatology alone, US healthcare may potentially save $2 billion every year. Confocal microscopy may also prove useful for noninvasively diagnosing and treating many other types of cancers such as oral, head-and-neck, breast and cervical.

描述（由申请人提供）：该项目的目标是将台式线扫描共聚焦显微镜转化为莫氏手术期间用于术中成像的临床仪器，并测试使用氯化铝作为对比剂对核形态进行反射染色来检测患者基底细胞癌（BCC）和鳞状细胞癌（SCC）边缘的可行性。达到临床预期的灵敏度和特异性将成为验证和展示皮肤莫氏手术和其他潜在多样化术中成像应用的技术平台的定量里程碑。其动机是创造一种相对简单、小型且低成本的共焦显微镜，用于反射实时成像，以指导不同环境下的手术。拟议的直接应用是术中绘制 BCC 和 SCC 来指导莫氏手术。未来的应用可能包括绘制癌症图谱，以指导口腔、头颈、乳房、膀胱、肝脏和其他组织的手术。 BCC 和 SCC 的发病率最高，仅在美国每年就估计诊断出 130 万例新病例，并估计进行 100 万例手术。手术以冰冻病理学为指导，既费力又耗时。共聚焦显微镜可对体内核细节进行成像，因此可以在术中直接对患者进行实时绘图。可以对手术暴露的原位组织进行癌症边缘的快速检查，以指导准确和完整的切除，同时保留周围的正常组织。成像可以作为病理学的辅助手段来指导手术，同时节省劳动力和成本。患者可能受益于更有效的手术、更少的麻醉和更少的手术室时间。初步结果证明了在患者手术暴露的原位刮取活检伤口中检测基底细胞癌的可行性，局部应用氯化铝以增强癌症与正常组织的对比度。此外，实验室台式线扫描共焦显微镜展示了体内人体皮肤核和细胞细节的出色成像。光学切片为1.7 µm，横向分辨率为0.8 µm，与病理切片相当。台式显微镜的硬件成本不到 15,000 美元。我们的假设是，台式线扫描仪器可以转化为紧凑型共焦显微镜，以便在床边使用。用氯化铝快速、安全地对核形态进行染色，可以在术中以反射对比的方式绘制 BCC 和 SCC 的图，从而指导手术。具体目标是 (1) 建立一个紧凑型线扫描共焦显微镜，用于术中反射对比成像，以及 (b) 在一项针对 60 名患者的试点临床研究中，测试显微镜和基于氯化铝的对比剂，用于莫氏手术期间原位手术伤口中 BCC 和 SCC 边缘的术中检测。将根据莫氏冷冻病理学的金标准确定敏感性和特异性，以验证该技术的可行性。公共健康相关性：共聚焦显微镜可以直接、实时地对患者进行皮肤癌的筛查和诊断，例如黑色素瘤、基底细胞癌和鳞状细胞癌，或者可以指导此类癌症的手术。筛查、诊断或手术指导可以是非侵入性的，对活检的需求最小，疼痛最小，费用也最小。仅在皮肤科领域，美国医疗保健每年就可能节省 20 亿美元。共聚焦显微镜也可能有助于非侵入性诊断和治疗许多其他类型的癌症，例如口腔癌、头颈癌、乳腺癌和宫颈癌。

项目成果

期刊论文数量（11）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Confocal imaging of carbon dioxide laser-ablated basal cell carcinomas: An ex-vivo study on the uptake of contrast agent and ablation parameters.

二氧化碳激光消融基底细胞癌的共焦成像：关于造影剂摄取和消融参数的离体研究。

DOI：
10.1002/lsm.22415
发表时间：
2016
期刊：
Lasers in surgery and medicine
影响因子：
2.4
作者：
Sierra,Heidy;Damanpour,Shadi;Hibler,Brian;Nehal,Kishwer;Rossi,Anthony;Rajadhyaksha,Milind
通讯作者：
Rajadhyaksha,Milind

Confocal microscopy-guided laser ablation for superficial and early nodular Basal cell carcinoma: a promising surgical alternative for superficial skin cancers.

DOI：
10.1001/jamadermatol.2013.10225
发表时间：
2014-09
期刊：
JAMA DERMATOLOGY
影响因子：
10.9
作者：
Chen, Chih-Shan Jason;Sierra, Heidy;Cordova, Miguel;Rajadhyaksha, Milind
通讯作者：
Rajadhyaksha, Milind

Patterns of the use of reflectance confocal microscopy at a tertiary referral dermatology clinic.

DOI：
10.1016/j.jaad.2021.11.054
发表时间：
2022-10
期刊：
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
影响因子：
13.8
作者：
Mehta, Paras P.;Oh, Yuna;Cordova, Miguel;Chen, Chih-Shan;Halpern, Allan;Harris, Ucalene;Kentley, Jonathan;Kurtansky, Nicholas R.;Kose, Kivanc;Lee, Erica H.;Marchetti, Michael A.;Marghoob, Ashfaq;Markova, Alina;Navarrete-Dechent, Cristian;Nehal, Kishwer;Rajadhyaksha, Milind;Rossi, Anthony;Sahu, Aditi;Sun, Mary;Jain, Manu;Rotemberg, Veronica
通讯作者：
Rotemberg, Veronica

Detection of skin cancer margins in Mohs excisions with high-speed strip mosaicing confocal microscopy: a feasibility study.