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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Squamous Cell Carcinoma of the Oral Cavity Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Hypopharynx Laryngeal Diseases Larynx Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Oropharynx Otorhinolaryngologic Diseases Respiratory Tract Diseases Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mount Sinai School of Medicine

New York, 10029-6574, United States

About this study

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:

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.
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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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)

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

William Marsh Rice University

Registry information

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Mar 24, 2011
Registry last updated: Jun 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed