Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium
20. juni 2012 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
64
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New York
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New York, New York, Forenede Stater, 10029-6574
- Mount Sinai School of Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients with new head and neck cancer, who reside in the tri-state area.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Accuracy and Interrater Reliability of HRME Image Interpretation
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2009
Primær færdiggørelse (Faktiske)
1. maj 2012
Studieafslutning (Faktiske)
1. maj 2012
Datoer for studieregistrering
Først indsendt
21. marts 2011
Først indsendt, der opfyldte QC-kriterier
22. marts 2011
Først opslået (Skøn)
24. marts 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
21. juni 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. juni 2012
Sidst verificeret
1. juni 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
- Strubehoved
- HRME
- Planocellulært karcinom
- Hypopharynx
- Oropharynx
- Kræftkirurgi
- Mundhule
- High-resolution microendoscope
- Optical imaging technology
- Non-invasive fluorescence and reflectance imaging
- Upper aerodigestive tract
- Squamous cell carcinoma of the oral cavity, oropharynx, larynx, and/or hypopharynx
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GCO # 09-0945
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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