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.
Squamous Cell Carcinoma of the Oral Cavity
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium|
- 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)
Biospecimen Retention: Samples Without DNA
Retained specimens are punch biopsy specimens from the primary tumor resection.
|Study Start Date:||June 2009|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
Squamous cell carcinoma
Patients included in this study will be receiving surgical treatment for their biopsy-proven squamous cell carcinoma.
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.
(1) To collect data to develop imaging algorithms to distinguish between normal and cancerous upper aerodigestive mucosa.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321892
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, 10029-6574|
|Principal Investigator:||Andrew Sikora, MD, PhD||Mount Sinai School of Medicine|