Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium
2012年6月20日 更新者：Icahn School of Medicine at Mount Sinai
The purpose of this research study is to collect information on whether images made using investigational microscopes can improve researchers' ability to evaluate and distinguish between normal and abnormal areas in tissue samples surgically removed from patients with squamous cell carcinoma.
The microscopes being used in this study are considered investigational because they have not been approved by the United States Food and Drug Administration (FDA) for finding abnormal or pre-cancerous areas.
研究概览
详细说明
The overall objective of this exploratory study is to evaluate whether noninvasive fluorescence and reflectance imaging of the upper aerodigestive tract can help clinicians more accurately determine intraoperative margins during ablative cancer surgery. This is an ex vivo study designed to evaluate the feasibility of using prototype optical imaging technology to enhance the discrimination between areas of noncancerous "normal" and cancerous mucosa. The results of this laboratory study will be used to further refine and develop this technology for in vivo application.
Primary Aim:
(1) To collect data to develop imaging algorithms to distinguish between normal and cancerous upper aerodigestive mucosa.
Secondary Aims:
- To compare the combination of wide-field fluorescence/reflectance and high resolution fluorescence microscopy images of upper aerodigestive epithelium to histopathologic analysis of biopsied tissue.
- To compare the ability of sequential wide-field/fluorescence microscopy imaging to discriminate between normal and cancerous oral cavity mucosa with that of white-light images obtained after staining with toluidine blue.
研究类型
观察性的
注册 (实际的)
64
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New York
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New York、New York、美国、10029-6574
- Mount Sinai School of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients with new head and neck cancer, who reside in the tri-state area.
描述
Inclusion Criteria:
- Subjects with biopsy-proven squamous cell carcinoma of the oral cavity, oropharynx, larynx, and/or hypopharynx.
- Must be receiving surgical treatment for their cancer.
Exclusion Criteria:
• Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Squamous cell carcinoma
Patients included in this study will be receiving surgical treatment for their biopsy-proven squamous cell carcinoma.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Accuracy and Interrater Reliability of HRME Image Interpretation
大体时间：baseline
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We will ask blinded raters to classify the HRME images as either benign (normal) or dysplastic/cancerous (abnormal)
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baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Feuer EJ, Kessler LG. Test statistic and sample size for a two-sample McNemar test. Biometrics. 1989 Jun;45(2):629-36. Erratum In: Biometrics 1989 Sep;45(3):1039.
- Blair EA, Callender DL. Head and neck cancer. The problem. Clin Plast Surg. 1994 Jan;21(1):1-7.
- Silverman S Jr, Sugerman PB. Oral premalignancies and squamous cell carcinoma. Clin Dermatol. 2000 Sep-Oct;18(5):563-8. doi: 10.1016/s0738-081x(00)00146-2. No abstract available.
- Schwarz RA, Gao W, Daye D, Williams MD, Richards-Kortum R, Gillenwater AM. Autofluorescence and diffuse reflectance spectroscopy of oral epithelial tissue using a depth-sensitive fiber-optic probe. Appl Opt. 2008 Feb 20;47(6):825-34. doi: 10.1364/ao.47.000825.
- Ramanujam N, Mitchell MF, Mahadevan A, Warren S, Thomsen S, Silva E, Richards-Kortum R. In vivo diagnosis of cervical intraepithelial neoplasia using 337-nm-excited laser-induced fluorescence. Proc Natl Acad Sci U S A. 1994 Oct 11;91(21):10193-7. doi: 10.1073/pnas.91.21.10193.
- Gillenwater A, Jacob R, Richards-Kortum R. Fluorescence spectroscopy: a technique with potential to improve the early detection of aerodigestive tract neoplasia. Head Neck. 1998 Sep;20(6):556-62. doi: 10.1002/(sici)1097-0347(199809)20:63.0.co;2-o.
- Pavlova I, Weber CR, Schwarz RA, Williams MD, Gillenwater AM, Richards-Kortum R. Fluorescence spectroscopy of oral tissue: Monte Carlo modeling with site-specific tissue properties. J Biomed Opt. 2009 Jan-Feb;14(1):014009. doi: 10.1117/1.3065544.
- Epstein JB, Zhang L, Poh C, Nakamura H, Berean K, Rosin M. Increased allelic loss in toluidine blue-positive oral premalignant lesions. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2003 Jan;95(1):45-50. doi: 10.1067/moe.2003.97.
- Epstein JB, Sciubba J, Silverman S Jr, Sroussi HY. Utility of toluidine blue in oral premalignant lesions and squamous cell carcinoma: continuing research and implications for clinical practice. Head Neck. 2007 Oct;29(10):948-58. doi: 10.1002/hed.20637.
- Martin IC, Kerawala CJ, Reed M. The application of toluidine blue as a diagnostic adjunct in the detection of epithelial dysplasia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1998 Apr;85(4):444-6. doi: 10.1016/s1079-2104(98)90071-3.
- Kerawala CJ, Beale V, Reed M, Martin IC. The role of vital tissue staining in the marginal control of oral squamous cell carcinoma. Int J Oral Maxillofac Surg. 2000 Feb;29(1):32-5.
- Genden EM, Desai S, Sung CK. Transoral robotic surgery for the management of head and neck cancer: a preliminary experience. Head Neck. 2009 Mar;31(3):283-9. doi: 10.1002/hed.20972.
- McNeil BJ, Weichselbaum R, Pauker SG. Speech and survival: tradeoffs between quality and quantity of life in laryngeal cancer. N Engl J Med. 1981 Oct 22;305(17):982-7. doi: 10.1056/NEJM198110223051704.
- Collier T, Lacy A, Richards-Kortum R, Malpica A, Follen M. Near real-time confocal microscopy of amelanotic tissue: detection of dysplasia in ex vivo cervical tissue. Acad Radiol. 2002 May;9(5):504-12. doi: 10.1016/s1076-6332(03)80326-4.
- Muldoon TJ, Pierce MC, Nida DL, Williams MD, Gillenwater A, Richards-Kortum R. Subcellular-resolution molecular imaging within living tissue by fiber microendoscopy. Opt Express. 2007 Dec 10;15(25):16413-23. doi: 10.1364/oe.15.016413.
- Rosenberg D, Cretin S. Use of meta-analysis to evaluate tolonium chloride in oral cancer screening. Oral Surg Oral Med Oral Pathol. 1989 May;67(5):621-7. doi: 10.1016/0030-4220(89)90286-7.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年6月1日
初级完成 (实际的)
2012年5月1日
研究完成 (实际的)
2012年5月1日
研究注册日期
首次提交
2011年3月21日
首先提交符合 QC 标准的
2011年3月22日
首次发布 (估计)
2011年3月24日
研究记录更新
最后更新发布 (估计)
2012年6月21日
上次提交的符合 QC 标准的更新
2012年6月20日
最后验证
2012年6月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- GCO # 09-0945
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