Confocal Laser Microlaryngoscopy (CLMx)

Washington University School of Medicine

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Laryngeal Dysplasia Laryngeal Neoplasm

Interventions

Fluorescein injection, USP 10%DRUG

-2.5 ml intravenous 10 minutes before procedure

Confocal laser microlaryngoscopyDEVICE

Biopsy (standard of care)PROCEDURE

KTP laser photoablation (standard of care)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient must be adults 18 years of age or older who present to clinic with a history of hoarseness and voice changes and are noted to have changes to their vocal folds that are concerning for the possibility of dysplasia or early stage malignancy. * Patient will have vocal fold leukoplakia or other abnormal epithelial changes. * Patient (or legally authorized representative) must be able to understand and willing to sign a written informed consent document. Exclusion Criteria: * Patient must not have a history of radiation to the neck. * Patient must not have a documented reaction to fluorescein * Patient must not have a previous history of laryngeal cancer. * Patient must not have a history of allergy or bronchial asthma. * Patient must not be pregnant or breastfeeding.

Outcomes

Primary Outcomes

Sensitivity of the CLM as measured by the proportion of dysplasia cases that are correctly identified by the probe

Time frame: Day of surgery (Day 1)

Specificity of the CLM as measured by the proportion of patients with neoplasm cases correctly identified by the probe

Time frame: Day of surgery (Day 1)

Accuracy of the CLM as measured by the proportion of cases correctly classified by the probe

-If the prevalence of the disease in the population is known, the accuracy of the test can be calculated bases on prevalence sensitivity, specificity using the formula: Sensitivity\*Prevalence + Specificity\*(1-Prevalence)

Time frame: Day of surgery (Day 1)

Data from ClinicalTrials.gov

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