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Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium

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ClinicalTrials.gov Identifier: NCT01321892
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : June 21, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Squamous Cell Carcinoma of the Oral Cavity Oropharynx Larynx Hypopharynx

Detailed Description:

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.

Study Design

Study Type : Observational
Actual Enrollment : 64 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium
Study Start Date : June 2009
Primary Completion Date : May 2012
Study Completion Date : May 2012
Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Accuracy and Interrater Reliability of HRME Image Interpretation [ Time Frame: baseline ]
    We will ask blinded raters to classify the HRME images as either benign (normal) or dysplastic/cancerous (abnormal)

Biospecimen Retention:   Samples Without DNA
Retained specimens are punch biopsy specimens from the primary tumor resection.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with new head and neck cancer, who reside in the tri-state area.

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321892

United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029-6574
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
William Marsh Rice University
Principal Investigator: Andrew Sikora, MD, PhD Icahn School of Medicine at Mount Sinai
More Information


Responsible Party: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT01321892     History of Changes
Other Study ID Numbers: GCO # 09-0945
First Posted: March 24, 2011    Key Record Dates
Last Update Posted: June 21, 2012
Last Verified: June 2012

Keywords provided by Icahn School of Medicine at Mount Sinai:
High-resolution microendoscope
Optical imaging technology
Non-invasive fluorescence and reflectance imaging
Upper aerodigestive tract
Cancer surgery
Squamous cell carcinoma
Oral cavity
Squamous cell carcinoma of the oral cavity, oropharynx, larynx, and/or hypopharynx

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell