NCT01321892|Completed
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Sponsor study identifier
observational
64
1 country
1
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2012
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
March 21, 2011
Actual (reported)March 24, 2011
Actual (reported)May 2012
Actual (reported)May 2012
Actual (reported)Accuracy and Interrater Reliability of HRME Image Interpretation
We will ask blinded raters to classify the HRME images as either benign (normal) or dysplastic/cancerous (abnormal)
baseline
Patients included in this study will be receiving surgical treatment for their biopsy-proven squamous cell carcinoma.
Patients with new head and neck cancer, who reside in the tri-state area.
Mount Sinai School of Medicine
New York, New York, 10029-6574, United States
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.
Retained specimens are punch biopsy specimens from the primary tumor resection.
Andrew Sikora, MD, PhD
Icahn School of Medicine at Mount Sinai
64 participants (actual enrollment reported by the registry).
First Submitted
March 21, 2011
First Posted
March 24, 2011
Study Start
June 2009
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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.
Feuer EJ, Kessler LG. Test statistic and sample size for a two-sample McNemar test. Biometrics. 1989 Jun;45(2):629-36.
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.
Primary Completion
May 2012
Actual (reported)Study Completion
May 2012
Actual (reported)Last Updated
June 21, 2012
Record last verified: 2012-06
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