Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium

NCT01321892 | Completed

• 1 other identifier: GCO # 09-0945
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Squamous Cell Carcinoma of the Oral Cavity; Oropharynx; Larynx; Hypopharynx

Keywords

HRME; High-resolution microendoscope; Optical imaging technology; Non-invasive fluorescence and reflectance imaging; Upper aerodigestive tract; Cancer surgery; Squamous cell carcinoma; Oral cavity; Oropharynx; Larynx; Hypopharynx; Squamous cell carcinoma of the oral cavity, oropharynx, larynx, and/or hypopharynx

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Squamous cell carcinoma

Patients included in this study will be receiving surgical treatment for their biopsy-proven squamous cell carcinoma.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with new head and neck cancer, who reside in the tri-state area.

You may qualify if:

• Subjects with biopsy-proven squamous cell carcinoma of the oral cavity, oropharynx, larynx, and/or hypopharynx.
• Must be receiving surgical treatment for their cancer.

You may not qualify if:

• Presence of medical or psychiatric condition affecting ability to give voluntary, informed consent.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• William Marsh Rice University: collaborator

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029-6574, United States

Location

Related Publications (16)

• Blair EA, Callender DL. Head and neck cancer. The problem. Clin Plast Surg. 1994 Jan;21(1):1-7.

  PMID: 8112003 BACKGROUND

• 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.

  PMID: 11134851 BACKGROUND

• 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.

  PMID: 18288232 BACKGROUND

• 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.

  PMID: 7937860 BACKGROUND

• 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.

  PMID: 9702544 BACKGROUND

• 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.

  PMID: 19256697 BACKGROUND

• 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.

  PMID: 12539026 BACKGROUND

• 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.

  PMID: 17764090 BACKGROUND

• 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.

  PMID: 9574954 BACKGROUND

• 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.

  PMID: 10691141 BACKGROUND

• 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.

  PMID: 18972413 BACKGROUND

• 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.

  PMID: 7278922 BACKGROUND

• 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.

  PMID: 12458875 BACKGROUND

• 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.

  PMID: 19550931 BACKGROUND

• Feuer EJ, Kessler LG. Test statistic and sample size for a two-sample McNemar test. Biometrics. 1989 Jun;45(2):629-36.

  PMID: 2765642 BACKGROUND

• 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.

  PMID: 2654801 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Retained specimens are punch biopsy specimens from the primary tumor resection.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Laryngeal Diseases; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neoplasms, Squamous Cell

Study Officials

• Andrew Sikora, MD, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 24, 2011
• Study Start: June 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 21, 2012

Record last verified: 2012-06

Locations

US (1)