Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium
|ClinicalTrials.gov Identifier: NCT01321892|
Recruitment Status : Completed
First Posted : March 24, 2011
Last Update Posted : June 21, 2012
|Condition or disease|
|Squamous Cell Carcinoma of the Oral Cavity Oropharynx Larynx Hypopharynx|
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.
|Study Type :||Observational|
|Actual Enrollment :||64 participants|
|Official Title:||Ex Vivo Multimodal Imaging of Upper Aerodigestive Epithelium|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Squamous cell carcinoma
Patients included in this study will be receiving surgical treatment for their biopsy-proven squamous cell carcinoma.
- 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
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|
|Principal Investigator:||Andrew Sikora, MD, PhD||Icahn School of Medicine at Mount Sinai|