Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium

Completed

• Conditions: Squamous Cell Carcinoma of the Oral Cavity; Oropharynx; Larynx; Hypopharynx

• Registration Number: NCT01321892
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

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.

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 Timeline

• Study Start: 2009-06
• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-24
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-20
• Last Update Posted: 2012-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy and Interrater Reliability of HRME Image Interpretation	baseline	We will ask blinded raters to classify the HRME images as either benign (normal) or dysplastic/cancerous (abnormal)

Trial Locations

Locations (1)

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States