An observational study in Squamous Cell Carcinoma of the Oral Cavity, Oropharynx and Larynx, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-21.
Sponsored by Icahn School of Medicine at Mount Sinai · Observational
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:
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 64 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with new head and neck cancer, who reside in the tri-state area.
Exclusion Criteria:
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
We will ask blinded raters to classify the HRME images as either benign (normal) or dysplastic/cancerous (abnormal)
Time frame: baseline
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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Icahn School of Medicine at Mount Sinai