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Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium

18 Years
Not Enrolling
Squamous Cell Carcinoma of the Oral Cavity, Oropharynx, Larynx, Hypopharynx

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Trial Information

Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium

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:

1. 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.

2. 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.

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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

Accuracy and Interrater Reliability of HRME Image Interpretation

Outcome Description:

We will ask blinded raters to classify the HRME images as either benign (normal) or dysplastic/cancerous (abnormal)

Outcome Time Frame:


Safety Issue:


Principal Investigator

Andrew Sikora, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mount Sinai School of Medicine


United States: Institutional Review Board

Study ID:

GCO # 09-0945



Start Date:

June 2009

Completion Date:

May 2012

Related Keywords:

  • Squamous Cell Carcinoma of the Oral Cavity
  • Oropharynx
  • Larynx
  • Hypopharynx
  • 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
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Laryngeal Diseases



Mount Sinai School of Medicine New York, New York  10029