Stopped: Lost funding/staff
The purpose of this study is to evaluate the accuracy and efficacy of using confocal laser microlaryngoscopy (CLM) as a tool to perform non-invasive, in vivo, real time pathologic assessment of laryngeal lesions. In order to achieve this purpose, this study will prospectively enroll patients with clinical evident laryngeal pathology concerning for cancer or dysplasia, who are scheduled to undergo a formal intraoperative biopsy of their lesion. While in the operating room, prior to performing a formal biopsy, CLM will be used to evaluate the area of pathology, surrounding tissue, and contralateral normal tissue. Then the biopsy will be performed, as per standard protocol, and the diagnostic results from CLM and the formal biopsy will be compared.
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Sensitivity of the CLM as measured by the proportion of dysplasia cases that are correctly identified by the probe
Timeframe: Day of surgery (Day 1)
Specificity of the CLM as measured by the proportion of patients with neoplasm cases correctly identified by the probe
Timeframe: Day of surgery (Day 1)
Accuracy of the CLM as measured by the proportion of cases correctly classified by the probe
Timeframe: Day of surgery (Day 1)