Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium

This study has been completed.
William Marsh Rice University
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
First received: March 21, 2011
Last updated: June 20, 2012
Last verified: June 2012

March 21, 2011
June 20, 2012
June 2009
May 2012   (final data collection date for primary outcome measure)
Accuracy and Interrater Reliability of HRME Image Interpretation [ Time Frame: baseline ] [ Designated as safety issue: No ]
We will ask blinded raters to classify the HRME images as either benign (normal) or dysplastic/cancerous (abnormal)
Same as current
Complete list of historical versions of study NCT01321892 on ClinicalTrials.gov Archive Site
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Not Provided
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Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium
Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium

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.

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.
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples Without DNA

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

Non-Probability Sample

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

  • Squamous Cell Carcinoma of the Oral Cavity
  • Oropharynx
  • Larynx
  • Hypopharynx
Not Provided
Squamous cell carcinoma
Patients included in this study will be receiving surgical treatment for their biopsy-proven squamous cell carcinoma.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
May 2012
May 2012   (final data collection date for primary outcome measure)

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.

18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States
GCO # 09-0945
Mount Sinai School of Medicine
Mount Sinai School of Medicine
William Marsh Rice University
Principal Investigator: Andrew Sikora, MD, PhD Mount Sinai School of Medicine
Mount Sinai School of Medicine
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP